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

Catalog Number 320801

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: 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 bd micro-fine¿ insulin syringe needle broke off in the patient's left thigh during use and had to be surgically removed.The following information was provided by the initial reporter, translated from german to english: "2 x broken off insulin needles of bd 12 mm within 7 tg (b)(6) 2019 left thigh and (b)(6) 2019 right thigh in the middle, must be removed surgically".

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned as of 18 november 2019 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.Cannot perform a dhr review due to an unknown lot number.As no samples and/or photo(s) were 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.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd micro-fine¿ insulin syringe needle broke off in the patient's left thigh during use and had to be surgically removed.The following information was provided by the initial reporter, translated from german to english: "2 x broken off insulin needles of bd 12 mm within 7 tg 03.09.2019 left thigh and 10.09.2019 right thigh in the middle, must be removed surgically.".

• Brand Name: BD MICRO-FINE INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9202445
• MDR Text Key: 175005785
• Report Number: 1920898-2019-01156
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320801
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention