MAUDE Adverse Event Report: BD BD EPILOR 7ML PLASTIC LUER LOK SYRINGE; LOSS OF RESISTANCE SYRINGE

Catalog Number 405291

Device Problem Positioning Problem (3009)

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

Event Type  Injury  

Event Description

The doctor states the syringe needle is going too far in and resistance can't be felt.One patient had to go to the hospital as a result of this incident.No further information is available.

Manufacturer Narrative

The sample has been received and is currently bring evaluated.Upon completion of the investigation, a supplemental report will be submitted.

• Brand Name: BD EPILOR 7ML PLASTIC LUER LOK SYRINGE
• Type of Device: LOSS OF RESISTANCE SYRINGE
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: amy odell ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652585
• MDR Report Key: 3815649
• MDR Text Key: 16447416
• Report Number: 2243072-2014-00090
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 405291
• Device Lot Number: 3298208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2014
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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