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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN; PISTON SYRINGE Back to Search Results
Model Number 328291
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while using bd ultra-fine¿ insulin syringes short needle 31g 3/10cc 5/16in when removing shield the hub separated from device.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that needle hub separated and shields were difficult to remove.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-09.Investigation summary: customer returned (b)(4) loose 3/10cc syringe.Customer states that the shields were difficult to remove and the needle hub separated.The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch # 9161979 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause for this defect cannot be determined.Capa1630423 has been opened to address this issue.
 
Event Description
It was reported while using bd ultra-fine¿ insulin syringes short needle 31g 3/10cc 5/16in when removing shield the hub separated from device.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that needle hub separated and shields were difficult to remove.
 
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Brand Name
BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11228286
MDR Text Key228621991
Report Number1920898-2021-00107
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282913
UDI-Public00382903282913
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328291
Device Catalogue Number328291
Device Lot Number9161979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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