MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICROFINE¿ INSULIN SYRINGE; INSULIN SYRINGE WITH NEEDLE

Catalog Number 324824

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that a bd microfine¿ insulin syringe had gray discoloration at syringe tip in front of protective cap.

Manufacturer Narrative

H.6.Investigation summary: customer returned (8) loose 1/2cc, 8mm syringes.Customer states that there is gray discoloration at syringe tip in front of protective cap.All returned syringes were examined under the microscope and all exhibited dark material smeared on the outer surface of the barrel ranging from the 0-10 unit markings.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely smeared ink.A review of the device history record was completed for batch# 8113592.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200753325] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (smeared ink).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.Based on the investigation, no capa is required at this time.Possible root cause is attributed to pad swelling on the mandril 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.

Event Description

It was reported that a bd microfine¿ insulin syringe had gray discoloration at syringe tip in front of protective cap.

• Brand Name: BD MICROFINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8191610
• MDR Text Key: 131334956
• Report Number: 1920898-2018-00971
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382904824013
• UDI-Public: 382904824013
• Combination Product (y/n): N
• PMA/PMN Number: K941657
• 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: 01/17/2019

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: 04/30/2023
• Device Catalogue Number: 324824
• Device Lot Number: 8113592
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other