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

Catalog Number 328521

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

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

Event Date 07/21/2019

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 tip of the syringes are crushed with a relion® insulin syringe.This occurred on 3 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: consumer reported 3 syringes cracked at the tip, stated that the syringes appear to have been crushed at the tip during the manufacturing process.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9091713.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200814800] noted for damaged cracked barrel.

Event Description

It was reported that the tip of the syringes are crushed with a relion® insulin syringe.This occurred on 3 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: consumer reported 3 syringes cracked at the tip, stated that the syringes appear to have been crushed at the tip during the manufacturing process.

Manufacturer Narrative

Investigation: customer returned three loose 31g x 6mm, 0.3ml relion insulin syringes.Consumer reported 3 syringes cracked at the tip, stated that the syringes appear to have been crushed at the tip.All three returned samples were examined, and it was observed that two syringes had cracked barrels.No other damage/issues was observed on the returned syringes.The cause of the cracked barrels likely occurred during the manufacturing process.A review of the device history record was completed for batch# 9091713.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted for damaged cracked barrel.

Event Description

It was reported that the tip of the syringes are crushed with a relion® insulin syringe.This occurred on 3 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: consumer reported 3 syringes cracked at the tip, stated that the syringes appear to have been crushed at the tip during the manufacturing process.

• 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: 8871435
• MDR Text Key: 153815381
• Report Number: 1920898-2019-00769
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: 00681131138383
• 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,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328521
• Device Lot Number: 9091713
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other