MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE

Model Number 328509

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle hub separated from the relion® insulin syringe during use when removing the shield.The following information was provided by the initial reporter: "1 syringe took shield off and needle hub assembly stayed within the shield".

Manufacturer Narrative

H.6.Investigation: customer returned (1) 1/2cc, 8mm, 31g relion syringe in an open poly bag from lot # 9070565.Customer states that they took the shield off and needle hub assembly stayed within the shield.The syringe was returned with the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch# 9070565.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200812808, 200812871] noted that did not pertain to the complaint.There was one (1) notification [200813047] noted for cracked hubs.There were no notifications or maintenance dispatches during the timeframe of this batch that pertain to this defect.Root cause for this defect cannot be determined.

Event Description

It was reported that the needle hub separated from the relion® insulin syringe during use when removing the shield.The following information was provided by the initial reporter: "1 syringe took shield off and needle hub assembly stayed within the shield.".

• Brand Name: RELION INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9521446
• MDR Text Key: 193650268
• Report Number: 1920898-2019-01472
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: 00681131311762
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328509
• Device Catalogue Number: 328509
• Device Lot Number: 9070565
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other