MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM

Catalog Number 328506

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Device manufacture date: 8/12/2016-8/15/2016.Results: it is unknown if a sample will be returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6179705.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that a needle from a bd relion® insulin syringe 1 ml, 31 g x 8 mm broke off in a consumer's injection site during use.The consumer saw a physician who made a small incision and removed the needle with a pair of tweezers.

• Brand Name: BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
• 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: 6339897
• MDR Text Key: 67712860
• Report Number: 1920898-2017-00025
• 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
• Report Date: 02/16/2017

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: 6179705
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention