MAUDE Adverse Event Report: BECTON DICKINSON BD DISPOSITIVO ASEPTO WING NEEDLE SET 27G

Catalog Number 388340

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2014

Event Type  Injury  

Event Description

It was reported that while using a 27 gauge bd dispositivo asepto wing needle set for a routine arterial puncture procedure on a neonatal patient, the needle broke off inside the patient's artery.An x-ray was done which visualized the retained needle in the patient's subcutaneous tissue in the right wrist.A surgery was then performed to remove the retained broken needle and the needle was removed successfully.

Manufacturer Narrative

The sample involved in the incident is not available, however, representative sample units will be returned.Once the representative sample is received, it will be evaluated and upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD DISPOSITIVO ASEPTO WING NEEDLE SET 27G
• Type of Device: WING NEEDLE SET
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ 07417 188
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417-1880 ; 5652406
• MDR Report Key: 4209596
• MDR Text Key: 4985386
• Report Number: 2243072-2014-00263
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/20/2014

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: 03/31/2018
• Device Catalogue Number: 388340
• Device Lot Number: 3077148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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