MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE X100L PR CLEAR SSL; ANTISTICK SYRINGE

Catalog Number 47440202

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 prior to use it was discovered that the plunger is bent in the syringe with a bd ultrasafe¿ x100l pr clear ssl.The following information was provided by the initial reporter: according to the complaint description, the pharmacist reported behalf of the nurse that the plunger of one syringe is bent.

Manufacturer Narrative

Investigation summary: one sample was provided to bd medical - pharmaceutical system (bdm-ps) for analysis and the customer also provided photographs of the reported condition.The batch involved in this complaint was manufactured and shipped by a bd supplier and met all acceptable quality levels (aql's) when shipped and were manufactured and released according to applicable procedures and specifications.Inspection of the sample and the photograph provided confirms the affected component is bent.The source of the damage cannot be verified.However, it was possible for the complaint investigator to replicate the issue on an undamaged sample which confirms the damage could have occurred at any point from moulding to end user.The reported condition is confirmed but within specification.

Event Description

It was reported that prior to use it was discovered that the plunger is bent in the syringe with a bd ultrasafe¿ x100l pr clear ssl.The following information was provided by the initial reporter: according to the complaint description, the pharmacist reported behalf of the nurse that the plunger of one syringe is bent.

• Brand Name: BD ULTRASAFE X100L PR CLEAR SSL
• Type of Device: ANTISTICK SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 8960434
• MDR Text Key: 156752905
• Report Number: 3001741852-2019-00039
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K122558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2020
• Device Catalogue Number: 47440202
• Device Lot Number: 1504940
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other