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

Catalog Number 328509

Device Problems Leak/Splash (1354); Material Twisted/Bent (2981)

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

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future, the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 8071816.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the relion® insulin syringe needle bent during injection and leaked.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned (5) loose 1/2cc, 8mm syringes.Customer states that the needle bends during injection and does not penetrate skin, medication leaks on to the injection site, and he cannot draw the medication.All returned syringes were examined and all exhibited a bent cannula.All samples were tested and all plunger rods were able to be exercised in the barrel properly, indicating that all syringes could draw and expel properly.Also, no points of possible leakage were observed on any of the samples.A review of the device history record was completed for batch# 8071816.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4),] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (leakage, unable to draw).

Event Description

It was reported that the relion® insulin syringe needle bent during injection and leaked.There was no report of exposure, injury, or medical intervention.

• 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 ; 8015652845
• MDR Report Key: 8065344
• MDR Text Key: 128047147
• Report Number: 1920898-2018-00855
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: 00681131311762
• 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: 11/27/2018

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 Catalogue Number: 328509
• Device Lot Number: 8071816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2018
• 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