MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number	328520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Investigation summary: samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for this lot.Three of the ten syringes featured their needle shields and hubs separated from the associated barrels.The hubs have become lodged inside their respective shields.There is no damage to the connectors at the distal tips of the barrels or their needle hubs.No signs of use and no other defects found.Investigation conclusion: bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause description: based on the samples received, bd was able to confirm the customer¿s indicated failure of needle hub detaching.Rationale: corrective/preventative action (capa) has been initiated.
Event or Problem Description
It was reported that syringe 0.5ml 31g 6mm s/c u-100 relion needle hub separates.The following information was provided by the initial reporter: material no: 328520 batch no: 9346553.It was reported when needle hub separates, needle shield difficult to remove.Verbatim: relion consumer reported, when needle shield was removed, needle hub separated prior to injection.Stated, needle shield was hard to remove.

• Brand Name: SYRINGE 0.5ML 31G 6MM S/C U-100 RELION
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11735246
• Report Number: 1920898-2021-00475
• Device Sequence Number: 4026616
• Product Code: FMF
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 9346553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1