MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ULTRA-FINE II¿ (SHORT) SELF CONTAINED INSULIN SYRINGE

Catalog Number 320469

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 01/01/2018

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 before use a bd¿ ultra-fine ii¿ (short) self contained insulin syringe was found with the ¿plunger rod very stiff and difficult to move.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: customer returned two 1cc, 8mm, 30g syringes in an open polybag from lot # 6291998.Customer states that the plunger rod is very stiff and difficult to move.Both returned syringes were tested and both plunger rods were able to be exercised in the barrel easily.As per manufacturing, a review of the device history record was completed for batch# 6291998.All inspections were performed per the applicable operations qc specifications.There was one notification noted that did not pertain to the complaint investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD¿ ULTRA-FINE II¿ (SHORT) SELF CONTAINED INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7311331
• MDR Text Key: 101530242
• Report Number: 1920898-2018-00139
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: 11/30/2021
• Device Catalogue Number: 320469
• Device Lot Number: 6291998
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other