MAUDE Adverse Event Report: BD BD INSULIN SYRINGE 12.7MM, 30G, 0.5ML; SYRINGE, PISTON

Lot Number 1074125

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Patient reports that he has been mailed 3 boxes of bd insulin syringes ndc# (b)(4) (1/2 ml 30g 12.7 mm) that have contained sealed bags with syringes in them that contain an unknown liquid.He brought in opened bags with the syringes containing liquid.The liquid appears clear and each syringe was drawn up to 3 units a large bubble in each.He claims neither he nor a family member drew them up ahead of time or put used needles back into the box.He doesn't have a diagnosis for any memory impairment on his chart.He uses 10 units of glargine and a carb ratio for his aspart insulin.He's concerned he may have mistakenly used some syringes with liquid in them because he says some only have a tiny drop in them and he can't see it very well.We still have the syringes in the pharmacy if needed.Fda safety report id# (b)(4).

• Brand Name: BD INSULIN SYRINGE 12.7MM, 30G, 0.5ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 13059631
• MDR Text Key: 282777237
• Report Number: MW5106182
• Device Sequence Number: 3
• Product Code: FMF
• UDI-Device Identifier: 0829328466
• UDI-Public: 0829-3284-66
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/16/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1074125
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White