MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

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.(b)(4).

Event Description

It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to depress.This occurred on 9 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: it was reported syringes that could not be fully depressed as the plunger could not be advanced fully.The syringes were in a box shipped to us.The faulty syringes were noted intermittently until iv treatment ended (b)(6) 2020.I have 9 faulty syringes; it is unclear how many more of the 12 remaining unused syringes in the box are defective.No injuries were sustained.I will be able to return the faulty syringes.

Event Description

It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to depress.This occurred on 9 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: it was reported syringes that could not be fully depressed as the plunger could not be advanced fully.1.The syringes were in a box shipped to us.The faulty syringes were noted intermittently until iv treatment ended (b)(6) 2020.2.I have 9 faulty syringes; it is unclear how many more of the 12 remaining unused syringes in the box are defective.3.No injuries were sustained.4.I will be able to return the faulty syringes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-01.H6: investigation summary a device history record review was completed for provided lot number 0223175.The review did reveal one non-conformance during the production process.This non-conformance was associated with dry barrels.This issue was resolved at the time of occurrence.To aid in the investigation of this incident, samples were returned for evaluation by our quality engineer team.Through inspection of the samples, the plunger exhibited difficult movement.It is possible that this incident resulted from an intermittent issue during production in which an incorrect dose of silicon was supplied into the barrel.Despite the related non-conformance being detected and resolved at the time of occurrence, it is possible that some faulty product was produced prior to detection.H3 other text : see h10.

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11168346
• MDR Text Key: 227082533
• Report Number: 9616657-2021-00004
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• PMA/PMN Number: K003553
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 306546
• Device Lot Number: 0223175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1