MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number 328519

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion needle broke off in arm during injection.The following information was provided by the initial reporter: material no.328519 batch no.9350453.It was reported that needle broke off in arm during injection.Was removed without medical attention.Verbatim: consumer reported finding needles bend while injecting of these few syringes from this box 2 of them broke off in arm.He was able to remove on his own.He claims these were new syringes.But has reused syringes in the past for long times under his doctor direction.

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion neelde broke off in arm during injection.The following information was provided by the initial reporter: material no.328519 batch no.9350453.It was reported that needle broke off in arm during injection.Was removed without medical attention.Verbatim: consumer reported finding needles bend while injecting of these few syringes from this box 2 of them broke off in arm.He was able to remove on his own.He claims these were new syringes.But has reused syringes in the past for long times under his doctor direction.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: (b)(6)2020.H6: investigation summary customer returned (10) 1cc, 6mm, 31g relion syringes in a sealed poly bag from lot # 9350453.Customer states that the needle broke off in arm during injection.All returned syringes were examined and no broken cannula was observed.A review of the device history record was completed for batch# 9350453.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10646208
• MDR Text Key: 212160241
• Report Number: 1920898-2020-01372
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9350453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other