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

Catalog Number 324826

Device Problems Out-Of-Box Failure (2311); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2017

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 discolorations were found inside bd micro-fine¿ insulin syringe needles prior to use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: nine (9) 3/10cc, 8mm, 30g syringes were returned in open poly bags from lot # 7044865.Customer states that there is discoloration inside the syringes.All returned syringes were examined under the microscope and all exhibited smeared ink on the surface of the barrel.No discoloration was observed inside the barrel.Capa (b)(4) was initiated to address such issues at this time.As per manufacturing, a review of the device history record was completed for batch # 7044865 all inspections were performed per the applicable operations qc specifications.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Investigation conclusion: possible root cause is attributed to pad swelling on the mandrill during the printing process.As the pads are used, they gradually swell and can cause this type of "smear" or "smudge affect.A problem solving team has been tasked with improving print quality on all production lines within the plant.The team is systematically assessing and addressing each printer individually for improvements.Capa (b)(4) was initiated to address such issues at this time.

• Brand Name: BD MICRO-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7154804
• MDR Text Key: 96124913
• Report Number: 1920898-2017-00403
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 324826
• Device Lot Number: 7044865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Date Manufacturer Received: 12/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other