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

Catalog Number 328521

Device Problems Air Leak (1008); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd relion® insulin syringe the ¿consumer reported air bubbles in her syringe and also one syringe with something on the needle appearing to be plastic or glue.Consumer does not re-use.¿ there was no report of medical intervention.

Manufacturer Narrative

Customer only returned a shelf carton and an open, empty poly bag from lot # 7037606.No syringes (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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# 7037606.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200684932] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for air bubbles and the 2nd related complaint for foreign matter on needle on lot # 7037606.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD RELION® INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7396960
• MDR Text Key: 104548206
• Report Number: 1920898-2018-00236
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138390
• UDI-Public: 00681131138390
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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: 7037606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other