• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD BD INSULIN SYRINGE 12.7MM, 30G, 0.5ML SYRINGE, PISTON Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSULIN SYRINGE 12.7MM, 30G, 0.5ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key13059631
MDR Text Key282777237
Report NumberMW5106182
Device Sequence Number3
Product Code FMF
UDI-Device Identifier0829328466
UDI-Public0829-3284-66
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number1074125
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 12/20/2021 Patient Sequence Number: 1
-
-