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

Catalog Number 320411

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 05/03/2018

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 the needle of the bd ultra-fine¿ insulin syringe broke off into the patients stomach during use.She was able to retrieve the needle using tweezers.She has no intention of seeking medical treatment or intervention.No reports of serious injury.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch # 1193243.All inspections and challenges were performed per the applicable operations qc specifications.There were zero notifications noted that pertained to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGES
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7530125
• MDR Text Key: 108807048
• Report Number: 1920898-2018-00350
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: Lay User/Patient
• Device Catalogue Number: 320411
• Device Lot Number: 1193243
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other