MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe's needle broke off in the users abdomen.The following information was provided by the initial reporter, translated from hungarian to english: i would like to share with you a story, an accident that happened to me while using the bd micro-fine pen needle (29g x 12.7mm).Last week, on friday, january 5, 2024, after administering insulin, the needle broke into my abdomen.I inserted it and when i took it out, the needle was still in me.I used it the same as i always have, i didn't move it after i inserted it.Unfortunately i am experienced in this, as i have been an insulin diabetic since 1999 and nothing like this has ever happened to me.I was very surprised, i found it strange.I went to the emergency room or the accident and emergency department, they x-rayed me, but unfortunately the needle was missing in my abdomen and the doctors could not remove it.Since they cut open my abdomen and i got a stitch, now i go for bandaging every other day and the stitch has to stay in for about 10 days.Since they couldn't remove it, there is the danger that it could cause a problem at any time.True, the doctors said it shouldn't, but they don't know for sure either.If you doubt what i am saying, i can provide medical paperwork to prove the case, but i didn't want to send that right now to protect my personal information.I would like to know how do you think this could have happened? i can only hope that i can live longer and not pay too high a price for this 'accident'.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe's needle broke off in the users abdomen.The following information was provided by the initial reporter, translated from hungarian to english: i would like to share with you a story, an accident that happened to me while using the bd micro-fine pen needle (29g x 12.7mm).Last week, on friday, on (b)(6) 2024, after administering insulin, the needle broke into my abdomen.I inserted it and when i took it out, the needle was still in me.I used it the same as i always have, i didn't move it after i inserted it.Unfortunately i am experienced in this, as i have been an insulin diabetic since 1999 and nothing like this has ever happened to me.I was very surprised, i found it strange.I went to the emergency room or the accident and emergency department, they x-rayed me, but unfortunately the needle was missing in my abdomen and the doctors could not remove it.Since they cut open my abdomen and i got a stitch, now i go for bandaging every other day and the stitch has to stay in for about 10 days.Since they couldn't remove it, there is the danger that it could cause a problem at any time.True, the doctors said it shouldn't, but they don't know for sure either.If you doubt what i am saying, i can provide medical paperwork to prove the case, but i didn't want to send that right now to protect my personal information.I would like to know how do you think this could have happened? i can only hope that i can live longer and not pay too high a price for this 'accident'.I went to the emergency room or the accident and emergency department, they x-rayed me, but unfortunately the needle was missing in my abdomen and the doctors could not remove it.Since they cut open my abdomen and i got a stitch, now i go for bandaging every other day and the stitch has to stay in for about 10 days.Since they couldn't remove it, there is the danger that it could cause a problem at any time.True, the doctors said it shouldn't, but they don't know for sure either.If you doubt what i am saying, i can provide medical paperwork to prove the case, but i didn't want to send that right now to protect my personal information.I would like to know how do you think this could have happened? i can only hope that i can live longer and not pay too high a price for this 'accident'.

Manufacturer Narrative

H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was not able to confirm the customer-indicated issue.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformance's were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18507385
• MDR Text Key: 332888829
• Report Number: 2243072-2024-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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