MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION INSULIN SYRINGE 1.0ML, 31G X 8MM

Catalog Number 328506

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 04/30/2016

Event Type  Injury  

Manufacturer Narrative

This device does not have an expiration date.It is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the needle from the suspect device broke off in site during injection.He removed the needle himself but went to the hospital for verification.It was confirmed with x-ray that the needle had been removed.The customer denied reuse of the device.

Manufacturer Narrative

Device evaluation: result - a samples was not received for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5180652.This device was manufactured between august 15, 2015 and august 16, 2015.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure.A potential root cause for breakage may be re-use.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD RELION INSULIN SYRINGE 1.0ML, 31G X 8MM
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5651426
• MDR Text Key: 45090601
• Report Number: 1920898-2016-00016
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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: 328506
• Device Lot Number: 5180652
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention