MAUDE Adverse Event Report: TAKEDA PHARMACEUTICALS AMERICA, INC. ENTYVIO AUTO INJECTOR; INJECTOR, PEN

Medical Device Problem Codes	Material Fragmentation (1261); Leak/Splash (1354)
Health Effect - Clinical Codes	Discomfort (2330); Skin Burning Sensation (4540); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Awaiting complaint sample to be returned to manufacturer.
Event or Problem Description
When the patient was injecting the entyvio, the needle/bevel broke inside of her.She needed to go to the emergency room for an ultrasound to verify that it was there, and it was, but it was too small to remove.The patient brought the pen to the er and they told her they were going to report it, and were using the pen to make the report.The rn did not know if the er has reported this yet or not and she does not know if they still have the pen.Follow-up information: on (b)(6) 2025: patient does not have sample as it was left with the er doctor.· was the box/carton dropped? no · were there any seals on the box/carton/tray broken or missing? no · when you inspect the pen, is there any damage? no · how long was the pen left out of refrigeration before use? 30 minutes · prior to injection, how long was the pen left unused after the purple cap was removed? removed cap and then use right away.· where did you inject? do you rotate the injection site regularly? yes - in abdomen, this time it was on left side of body.· how did you place the pen on the skin (i.E the angle between the pen and the skin)? straight down.· how did you push the pen to the skin? did you push all the way down until it stopped or could not go further down? yes · did you hold the pen with constant pressure until you removed the pen from the skin? yes · when did you lift the pen from the skin to complete the injection: o when the 1st click was heard? yes did hear 1 click o when the 2nd click was heard? yes did hear 2nd click.O after holding for 10 seconds? yes - was pressed fully, perhaps there was a second or two short because of the pain.O when the viewing window was filled with purple? yes it was filled upon removing.· did the needle pierce the skin? - yes · if leakage was observed, when did the leakage happen, choose one below o before placing the pen on the skin? no o during placing the pen on the skin? no o after removing the pen from the skin? yes - after removal · if leakage was observed, where was the leaking medication? o on skin - yes and had blood o from the needle? did not notice anything from needle.· if leakage was observed, is it possible to quantify (droplet, large amount or something in between?) saw a few drops after injection and was a mixture of blood.· did you receive training on how to use the pen? if so, who trained you? - yes - by a nurse that works with the family doctor, over zoom.This was a year ago when patient first started on entyvio sub q.Additional questions that were asked: what symptoms did you experience immediately after the injection? - immediately saw a bubble after injection.She went to feel the bubble, felt something hard inside her.Skin was swelling which got larger, and skin got firmer.Have you had any previous reactions or issues with entyvio or similar devices? no, this was the first time.Were there any follow-up treatments or monitoring after the incident? the er did an ultrasound which could not see the fragment.A 2nd ultrasound was done by the radiologist, 2nd ultrasound saw the needle fragment in the skin.To date after discussing with the dr, the decided to leave the metal shard inside patients body as this was the tip of the needle.Doctor indicated her body would grow around the fragment in time.How are you feeling now? have you experienced any ongoing symptoms since the incident? the day of the incident, there was pain and burning sensations.It did sting for 24 hours, some residual swelling for about a week, swollen skin.The pain and swelling has reduced since the incident.Patient was able to shine a light down into the pen while in the er.Doctor was able to see where the needle broke (tip) on the device.The er doctor who performed the 2nd ultrasound that could see the foreign body in the skin.The fragment was 6mm deep into the skin surface.Would you describe your experience with the device as typical or atypical prior to this incident? patient has been using entyvio sub q for over a year, this is the first time she has seen a problem.The use of the pen was normal, right up until the pen broke.Have used the pen for one more time after this without any issue.However, since this issue, she has reverted back to entyvio vial for infusions.At what point did you notice the needle tip had broken? was it at the beginning of the injection? injection was completed, both clicks were heard and viewing window was full.Patient removed the pen like normal, however it was burning which was a typical for her injections.Upon removal she saw bubble on her skin.How small is the fragment left in the body? would it be possible to obtain details from the ultrasound results so that our medical group can better assess the situation? size of needle fragment was not provided.Doctors said it was small enough to not travel thru the body.The doctor could not find the fragment, however the radiologist found it.Ms called hospital again, doctor was not available, sample and ultrasound results are still unknown.Call back information was provided to hospital.
Event or Problem Description
When the patient was injecting the entyvio, the needle/bevel broke inside of her.She needed to go to the emergency room for an ultrasound to verify that it was there, and it was, but it was too small to remove.The patient brought the pen to the er and they told her they were going to report it, and were using the pen to make the report.The rn did not know if the er has reported this yet or not and she does not know if they still have the pen.Follow-up information: 12 sep 2025: patient does not have sample as it was left with the er doctor.Was the box/carton dropped? no were there any seals on the box/carton/tray broken or missing? no when you inspect the pen, is there any damage? no how long was the pen left out of refrigeration before use? 30 minutes prior to injection, how long was the pen left unused after the purple cap was removed? removed cap and then use right away.Where did you inject? do you rotate the injection site regularly? yes - in adomen, this time it was on left side of body.How did you place the pen on the skin (i.E the angle between the pen and the skin)? straight down.How did you push the pen to the skin? did you push all the way down until it stopped or could not go further down? yes did you hold the pen with constant pressure until you removed the pen from the skin? yes when did you lift the pen from the skin to complete the injection: when the 1st click was heard? yes did hear 1 click when the 2nd click was heard? yes did hear 2nd click.After holding for 10 seconds? yes - was pressed fully, perhaps there was a second or two short because of the pain.When was the viewing window filled with purple? yes, it was filled upon removing.Did the needle pierce the skin? - yes if leakage was observed, when did the leakage happen, choose one below before placing the pen on the skin? no during placing the pen on the skin? no after removing the pen from the skin? yes - after removal if leakage was observed, where was the leaking medication? on skin - yes and had blood from the needle? did not notice anything from needle.If leakage was observed, is it possible to quantify (droplet, large amount or something in between?) saw a few drops after injection and was a mixture of blood.Did you receive training on how to use the pen? if so, who trained you? - yes - by a nurse that works with the family doctor, over zoom.This was a year ago when patient first started on entyvio sub q.Additional questions that were asked: what symptoms did you experience immediately after the injection? - immediately saw a bubble after injection.She went to feel the bubble, felt something hard inside her.Skin was swelling which got larger, and skin got firmer.Have you had any previous reactions or issues with entyvio or similar devices? no, this was the first time.Were there any follow-up treatments or monitoring after the incident? the er did an ultrasound which could not see the fragment.A 2nd ultrasound was done by the radiologist, 2nd ultrasound saw the needle fragment in the skin.To date after discussing with the dr, the decided to leave the metal shard inside patients body as this was the tip of the needle.Doctor indicated her body would grow around the fragment in time.How are you feeling now? have you experienced any ongoing symptoms since the incident? the day of the incident, there was pain and burning sensations.It did sting for 24 hours, some residual swelling for about a week, swollen skin.The pain and swelling has reduced since the incident.Patient was able to shine a light down into the pen while in the er.Doctor was able to see where the needle broke (tip) on the device.The er doctor who performed the 2nd ultrasound that could see the foreign body in the skin.The fragment was 6mm deep into the skin surface.Would you describe your experience with the device as typical or atypical prior to this incident? patient has been using entyvio sub q for over a year, this is the first time she has seen a problem.The use of the pen was normal, right up until the pen broke.Have used the pen for one more time after this without any issue.However, since this issue, she has reverted back to entyvio vial for infusions.At what point did you notice the needle tip had broken? was it at the beginning of the injection? injection was completed, both clicks were heard and viewing window was full.Patient removed the pen like normal, however it was burning which was a typical for her injections.Upon removal she saw bubble on her skin.How small is the fragment left in the body? would it be possible to obtain details from the ultrasound results so that our medical group can better assess the situation? size of needle fragment was not provided.Doctors said it was small enough to not travel thru the body.The doctor could not find the fragment, however the radiologist found it.Ms called hospital again, doctor was not available, sample and ultrasound results are still unknown.Call back information was provided to hospital.
Additional Manufacturer Narrative
Based on the available information in the complaint description and follow up information, no noticeable use errors were identified that would contribute to needle breakage.As the complaint sample was not returned nor was the lot number available, the potential root cause related to device is unable to be identified.

• Brand Name: ENTYVIO AUTO INJECTOR
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): TAKEDA PHARMACEUTICALS AMERICA, INC.; 500 kendall street; cambridge MA 02142
• Manufacturer (Section G): TAKEDA PHARMACEUTICALS U.S.A, INC.; 95 hayden avenue; lexington MA 02421
• Manufacturer Contact: christopher karner ; 500 kendall street; cambridge, MA 02142
• MDR Report Key: 23103210
• Report Number: 2032282-2025-00014
• Device Sequence Number: 13003754
• Product Code: NSC
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELAVIL (AMITRIPTYLINE HYDROCHLORIDE); ELAVIL (AMITRIPTYLINE HYDROCHLORIDE); IVABRADINE (IVABRADINE); IVABRADINE (IVABRADINE); OMEPRAZOLE (OMEPRAZOLE); OMEPRAZOLE (OMEPRAZOLE); ONDANSETRON (ONDANSETRON); ONDANSETRON (ONDANSETRON); PROMETHAZINE (PROMETHAZINE); PROMETHAZINE (PROMETHAZINE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White