MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿ PLUS INSULIN SYRINGE

Catalog Number 320933

Device Problem Difficult to Advance (2920)

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

Event Date 05/09/2018

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 during use a bd micro-fine¿ plus insulin syringe malfunctioned as "during the injection of the medicine (they use it especially for the sclerotherapy) the piston of the syringes is very hard to move and they experience some difficulties of injection of the medicine." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Customer returned two 1/2cc, 8mm, 30g syringes in an open poly bag with part of the shelf carton from lot # 7086621.Customer states that during the injection, the piston of the syringes is very hard to move and they experience some difficulties of injection of the medicine.Both returned syringes were tested and both plunger rods were able to be moved in the barrel and both were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 7086621.All inspections and challenges were performed per the applicable operations qc specifications.There were four notifications noted that did not pertain to the complaint.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 MICRO-FINE¿ PLUS INSULIN SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7550218
• MDR Text Key: 109637759
• Report Number: 1920898-2018-00361
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 320933
• Device Lot Number: 7086621
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other