MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 328821

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the hub separated from the device during use with a bd ultra-fine¿ ii insulin syringe.The following information was provided by the initial reporter: needle of insulin syringe was detached to cap upon opening.The customer claimed this happened for 3 pieces in the same polybag.

Manufacturer Narrative

H.6.Investigation summary: customer returned (1) loose 1/2cc syringe.Customer states that the needle of insulin syringe was detached to cap upon opening.The syringe was returned with the hub-needle/shield assembly separated from the barrel.Unable to perform dhr check for needle hub separates due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.As per investigation completed by manufacturing, "on 03jan2020, holdrege received a complaint, via a picture, from material 328821, unknown batch number.Visual inspection of the picture showed the needle assembly separated from the barrel.There did not appear to be any damage to the barrel tip.Process summary: the automatic syringe assembly machine feeds 0.5ml syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Due to the unknown batch number, it is not possible to review the quality notifications or maintenance dispatches for the time frame that this product was produced.Root cause for the defect cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.".

Event Description

It was reported that the hub separated from the device during use with a bd ultra-fine¿ ii insulin syringe.The following information was provided by the initial reporter: needle of insulin syringe was detached to cap upon opening.The customer claimed this happened for 3 pieces in the same polybag.

• Brand Name: BD ULTRA-FINE II INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9528022
• MDR Text Key: 180037705
• Report Number: 1920898-2019-01481
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328821
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other