MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 31GA 8MM 100 BX 1200 USA; Syringe, piston

Model Number 320109

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not available.

Event Description

Consumer reported patient end of pen needle broke off in his stomach during injection.Stated, the issue occurred twice but he does not remember when.Stated, he went to the emergency room but he does not know when and did not have documentation, but he could get it at a later date.Stated, he had 3 x-rays done and he may need surgery.Stated, he can feel the needle in his injection site.Stated, he does not re-use pen needles.Stated, he wants to be compensated for pain and suffering.Stated, he wants to be compensated for being in the emergency room for 8 hours.Discarded the used product hub.Stated, he is going to get a lawyer.Lot: 2348496.Catalog: 320109.Date of event: unknown.Samples: yes, (unused) cl.

• Brand Name: PEN NDL 31GA 8MM 100 BX 1200 USA
• Type of Device: Syringe, piston
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18698750
• MDR Text Key: 335294266
• Report Number: 9616656-2024-05082
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 320109
• Device Lot Number: 2348496
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1