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

Catalog Number 326666

Device Problem Material Separation (1562)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the needle shield on a bd ultra-fine¿ insulin syringe separated.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: customer returned photos of a 1/2cc syringe.Customer states that the needle shield was detached.The attached photos were examined and exhibited the syringe with the hub-needle/shield assembly separated from the barrel.No damage to the barrel was observed.Capa 97451 has been opened to address this issue.Severity: s_1__; occurrence: unable to perform complaint lot history check due to unknown lot number.Unable to perform complaint lot history check due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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 above, no additional investigation is required at this time.

Event Description

It was reported that the needle shield on a bd ultra-fine¿ insulin syringe separated.No serious injury or medical intervention was reported.

• Brand Name: BD ULTRA-FINE¿ 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: 7872870
• MDR Text Key: 120387010
• Report Number: 1920898-2018-00704
• Device Sequence Number: 1
• Product Code: FMF
• 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: 09/20/2018

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 Catalogue Number: 326666
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other