MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 30GX1/2"; INSULIN SYRINGE AND NEEDLE

Catalog Number 328466

Device Problems Break (1069); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6235614.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 of a bd insulin syringe with the bd ultra-fine¿ needle 0.5ml 30gx1/2" broke off when a consumer inserted it into an insulin vial.The needle fell to the floor and the consumer stepped on it.She was evaluated by an orthopedic physician and received x-rays, but the needle was not removed.This has caused pain and discomfort with ambulation and the consumer is unable to walk.A shoe cushion was also inserted in the customer shoe.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 30GX1/2"
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: 6614935
• MDR Text Key: 76767314
• Report Number: 1920898-2017-00068
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/15/2017

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: 328466
• Device Lot Number: 6235614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention