MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 31 G X 6MM BD ULTRA-FINE¿ INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE

Catalog Number 324915

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).A sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Without a sample, an absolute root cause for this incident cannot be determined.A sample is not available for evaluation.

Event Description

It was reported that while using a 31 g x 6mm bd ultra-fine insulin syringe, the needle broke off in the consumer's right arm.The consumer went to an emergency department and received an x-ray that visualized the broken needle.The consumer was given the option to have surgery to remove the broken needle or to allow her body to naturally discard it.The consumer chose to wait for her body to naturally discard the broken needle.

• Brand Name: 31 G X 6MM BD ULTRA-FINE¿ INSULIN SYRINGE
• 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: 5481333
• MDR Text Key: 39743162
• Report Number: 1920898-2016-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324915
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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