MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306575

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use of the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% there was no labeling.The following information was provided by the initial reporter: no labeling.

Event Description

It was reported that before use of the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% there was no labeling.The following information was provided by the initial reporter: no labeling.

Manufacturer Narrative

Investigation: bd has been provided with photos and a sample for catalog 306575 to investigate for this record.One sample without it's flow warp was received.The sample had a scratch at the syringe barrel and does not have label attached.As a result, bd was able to verify the reported issue based on the photos provided.Syringes with no label are typically rejected by the machine.In this case, due to a punctual failure, the syringe could have been stuck on the rejection stations and finally went to the good rail and packaged.

• Brand Name: BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8568884
• MDR Text Key: 143989089
• Report Number: 2243072-2019-00826
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306575
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other