MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE¿ PLUS X100L PNG CLEAR; PISTON SYRINGE

Catalog Number 47451101

Device Problem Protective Measures Problem (3015)

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

Event Date 12/15/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd ultrasafe¿ plus x100l png clear experienced safety failure.

Manufacturer Narrative

Investigation summary: dhr- batch record review did not indicate any failures related to the reported condition.Unconfirmed, no sample received.There are two points on the assembly line where 100% automated inspection would have rejected the device with the bent fingers.One is stationed prior to the loading of the guard to the main line and the other is the final inspection.Each device is placed into a purpose designed tray in order to ensure no damage occurs during transport.Therefore whilst bdm-ps was able to confirm the symptom reported by the customer, this symptom could not be correlated with a potential cause linked entirely to the bd process.

Event Description

It was reported that the bd ultrasafe¿ plus x100l png clear experienced safety failure.

• Brand Name: BD ULTRASAFE¿ PLUS X100L PNG CLEAR
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 8303287
• MDR Text Key: 134972032
• Report Number: 3001741852-2019-00001
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K123743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 47451101
• Device Lot Number: 6104467
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other