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

Model Number 328521

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

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 syringe was being used on the consumer's pet.This occurred on 5 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "pet owner reported when she removes the needle shield, needle and hub remains inside the needle shield.It happened 5 times on different days.Pet owner uses 31g, 6mm, 3/10ml syringes for her pet.".

Manufacturer Narrative

Investigation: : no samples (including photos) were returned as of 10 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch #9133810.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification [200827854] noted for cracked hubs.

Event Description

It was reported that the needle hub separated from the relion® insulin syringe during use when removing the shield.The syringe was being used on the consumer's pet.This occurred on 5 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "pet owner reported when she removes the needle shield, needle and hub remains inside the needle shield.It happened 5 times on different days.Pet owner uses 31g, 6mm, 3/10ml syringes for her pet.".

• Brand Name: RELION INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9521445
• MDR Text Key: 177748869
• Report Number: 1920898-2019-01471
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: 00681131138383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328521
• Device Catalogue Number: 328521
• Device Lot Number: 9133810
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other