MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ STERILE INSULIN SYRINGE

Catalog Number 328421

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

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 plunger of the bd¿ sterile insulin syringe was difficult to use.The customer tried to inject the drug solution but met resistance from the plunger.Found during use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the related 1st complaint reported for the defect/condition on lot number 6074716.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# 6074716.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications (b)(4) noted that did not pertain to the complaint.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.

• Brand Name: BD¿ STERILE INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7232684
• MDR Text Key: 98880291
• Report Number: 1920898-2018-00053
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

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: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 328421
• Device Lot Number: 6074716
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other