MAUDE Adverse Event Report: BD 27GA X 3/4IN NEEDLE; LARGE BORE NEEDLE

Catalog Number 302200

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2014

Event Type  Injury  

Event Description

The needle broke and remained in the patient, causing the operation to be delayed.Carbocaine/adrenaline were being injected subcutaneously at the time to numb the skin.An x-ray and examination were performed and the operator of the device opened a 5cm wound to look up the needle.The wound was sutured later and patched up.A second x-ray was performed (b)(6) 2014 and the decision was made that surgery was not required.The doctor expects the needle to stay in the soft portion of the tissue and encapsulate.

Manufacturer Narrative

Representative samples are available for evaluation.Upon completion of the investigation, a supplemental report will be submitted.

• Brand Name: 27GA X 3/4IN NEEDLE
• Type of Device: LARGE BORE NEEDLE
• Manufacturer (Section D): BD; one becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD; ctra. mequinenza s/n; fraga, ruesca 2252 0; SP 22520
• Manufacturer Contact: amy bodell ; one becton dr.; franklin lakes, NJ 07417 ; 8015652585
• MDR Report Key: 3862972
• MDR Text Key: 4462782
• Report Number: 2243072-2014-00120
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 302200
• Device Lot Number: 140115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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