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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.".
Event or Problem Description
It was reported that a syringe 0.5ml 31g 6mm s/c u-100 relion separated from the hub before use.The following was reported by the initial reporter: "it was reported that the consumer found one syringe with the needle hub missing.Verbatim: consumer reported found 1 syringe with the needle hub missing.Thinking its in the shield lot # 8203846, catalog# 328520, date of event (b)(6) 2021, sample status awaiting sample.".
Event or Problem Description
It was reported that a syringe 0.5ml 31g 6mm s/c u-100 relion separated from the hub before use.The following was reported by the initial reporter: "it was reported that the consumer found one syringe with the needle hub missing.Verbatim: consumer reported found 1 syringe with the needle hub missing.Thinking its in the shield lot # 8203846, catalog# 328520, date of event: (b)(6) 2021.Sample status awaiting sample.".
Additional Manufacturer Narrative
Correction: d2: medical device manufacturer: bd medical: diabetes care.G2: manufacturing location: bd medical: diabetes care.The following fields were updated due to additional information: d4: medical device lot #: 9203946.D4: medical device expiration date: unknown.H4: device manufacture date: 2019-08-27.D10: device available for eval yes.D10: returned to manufacturer on: 2021-04-30.H6: investigation summary: customer returned a single syringe in a polybag labeled for 0.5ml, 31 gauge, 6mm syringes from lot #9203946.The syringe had its needle shield and hub separated from the barrel.The hub has become lodged inside the shield.The connector itself is damaged, with a section on one side broken off and the neighboring material warped backwards towards the rest of the barrel.This is most likely the result of the stresses building up on the connector while attempting to remove the stuck needle shield.Additionally, there is a mark on the lip of the needle hub¿s base, further indicating stress on the system at an angle where the connector broke.A review of the device history record was completed for batch# 9203946.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the sample received, bd was able to confirm the customer¿s indicated failure of needle hub separation.Capa (b)(4) has been opened to address this issue.

• 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: 11750306
• Report Number: 2243072-2021-01295
• Device Sequence Number: 4268695
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 9203946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1