MAUDE Adverse Event Report: BD BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305269

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported that while using a bd integra syringe that the needle broke off of the syringe and embedded into the patient instead of retracting.The patient had surgery to try and remove the needle but the surgeon was unable to find and remove it.The surgical site was closed with sutures, an x-ray was done and the needle was visualized.It was determined that the needle was not causing any harm so the needle was left in the patient.It is reported that no further interventions will be done.

Manufacturer Narrative

Device was thrown in sharps container and will not be sent for evaluation.A review of the device history records revealed no irregularities during the manufacture of reported lot number 3206399.Conclusion: without a sample, a root cause for this incident could not be determined.

• Brand Name: BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD; one becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD; medical route 7 and grace way; p.o. box 749; canaan CT 06018
• Manufacturer Contact: aaron larson ; one becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4118133
• MDR Text Key: 4702733
• Report Number: 2243072-2014-00186
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/09/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 305269
• Device Lot Number: 3206399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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