MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE W/NEEDLE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that during use with an unspecified bd syringe w/needle the user heard a "pop", he then noticed the needle had disappeared.Patient went to er where an ultrasound was given.Was referred to a surgeon.An x-ray and additional ultrasound was performed, needle was not detected.Upon inspection of device it was discovered that the needle had retracted into itself.It was reported by the customer that "i wanted to report a faulty syringe.My dad was giving himself one of his vitamin shots at home this weekend.He heard a popping noise and felt a sting.It appeared that the needle from the syringe was stuck in him because it had disappeared and was nowhere to be found.He had to go to the er and have an ultrasound.They claimed they found the needle and referred him to a surgeon.Monday, (5/15) he went, and they did x-rays and could not find the needle and ordered another ultrasound.He has yet to have that second ultrasound.Last night, he found a spring on the floor.That led him to further inspecting the syringe.He cut it open and found the actual needle.No one at the er found it when he took it with him saturday evening.There is no warning label on the product itself.There is no material that comes with the syringes to explain this "safety" feature.This in turn caused multiple visits to doctors and piling on the medical bills.We are not medical professionals.We have never been warned of issues with syringes".Verbatim: hello! i wanted to report a faulty syringe.My dad was giving himself one of his vitamin shots at home this weekend.He heard a popping noise and felt a sting.It appeared that the needle from the syringe was stuck in him because it had disappeared and was nowhere to be found.He had to go to the er and have an ultrasound.They claimed they found the needle and referred him to a surgeon.Monday, (5/15) he went and they did x-rays and could not find the needle and ordered another ultrasound.He has yet to have that second ultrasound.Last night, he found a spring on the floor.That led him to further inspecting the syringe.He cut it open and found the actual needle.No one at the er found it when he took it with him saturday evening.There is no warning label on the product itself.There is no material that comes with the syringes to explain this "safety" feature.This in turn caused multiple visits to doctors and piling on the medical bills.We are not medical professionals.We have never been warned of issues with syringes.This is a situation that i feel needs to be addressed.Sincerely, a very annoyed consumer.

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.See h10.

Event Description

It was reported that during use with an unspecified bd syringe w/needle the user heard a "pop", he then noticed the needle had disappeared.Patient went to er where an ultrasound was given.Was referred to a surgeon.An x-ray and additional ultrasound was performed, needle was not detected.Upon inspection of device it was discovered that the needle had retracted into itself.It was reported by the customer that "i wanted to report a faulty syringe.My dad was giving himself one of his vitamin shots at home this weekend.He heard a popping noise and felt a sting.It appeared that the needle from the syringe was stuck in him because it had disappeared and was nowhere to be found.He had to go to the er and have an ultrasound.They claimed they found the needle and referred him to a surgeon.Monday, (5/15) he went, and they did x-rays and could not find the needle and ordered another ultrasound.He has yet to have that second ultrasound.Last night, he found a spring on the floor.That led him to further inspecting the syringe.He cut it open and found the actual needle.No one at the er found it when he took it with him saturday evening.There is no warning label on the product itself.There is no material that comes with the syringes to explain this "safety" feature.This in turn caused multiple visits to doctors and piling on the medical bills.We are not medical professionals.We have never been warned of issues with syringes".Verbatim: hello! i wanted to report a faulty syringe.My dad was giving himself one of his vitamin shots at home this weekend.He heard a popping noise and felt a sting.It appeared that the needle from the syringe was stuck in him because it had disappeared and was nowhere to be found.He had to go to the er and have an ultrasound.They claimed they found the needle and referred him to a surgeon.Monday, (5/15) he went and they did x-rays and could not find the needle and ordered another ultrasound.He has yet to have that second ultrasound.Last night, he found a spring on the floor.That led him to further inspecting the syringe.He cut it open and found the actual needle.No one at the er found it when he took it with him saturday evening.There is no warning label on the product itself.There is no material that comes with the syringes to explain this "safety" feature.This in turn caused multiple visits to doctors and piling on the medical bills.We are not medical professionals.We have never been warned of issues with syringes.This is a situation that i feel needs to be addressed.Sincerely, a very annoyed consumer,.

• Brand Name: UNSPECIFIED BD SYRINGE W/NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17106684
• MDR Text Key: 317160636
• Report Number: 2243072-2023-01000
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention