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

Catalog Number 328279

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 needle separation from the hub was found post investigation.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for shield difficult to remove/detach and the 1st related complaint for needle separates from hub on lot # 6179910.As per manufacturing, a review of the device history record was completed for batch# 6179910.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200649492] noted for cracked hubs.There was one (1) notification [200652453] noted that did not pertain to the complaint.Investigation summary: customer returned (2) 1/2cc, 12.7mm, 30g syringes in an open poly bag from lot # 6179910.Customer states that the shield is very hard to remove.Both returned syringes were tested to determine the shield removal forces (specs: shield removal force for 1/2cc after sterilization: 0.85-5.95 lbs.).Data: shield removal force syringe 1 4.02 lbs.Syringe 2 2.69 lbs.Both removal forces fall within specification.Also, no cannula separated from the hub.Conclusion: based on the samples received the investigation concluded that 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.Based on the above, no additional investigation and no capa is required at this time.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.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7265349
• MDR Text Key: 100003932
• Report Number: 1920898-2018-00095
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328279
• Device Lot Number: 6179910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Date Manufacturer Received: 12/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other