MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS; SYRING/PISTON

Catalog Number 306572

Device Problems Use of Device Problem (1670); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that bd posiflush xs stopper separated from plunger.The following information was provided by the initial reporter, translated from french to english: i hereby inform you of an incident concerning the device: bd posiflush xs syringe 0.9% nacl 10 ml (saline rinse syringe) problem encountered: when using the 3-piece syringe, the plunger is not properly welded and comes back in our hand.When screwed back in, the system doesn't hold.It is possible to inject, but not to reaspirate.This incident occurred 3 times (04/10, 05/10, 11/10) with 3 different syringes (bearing the same batch number) and by 2 different nurses.The device is available from the pharmacy for expert appraisal.Here are the answers to your questions: was there any impact on the patient (serious injury, medical intervention, change in treatment required)? no.Did the malfunction cause a needle-stick injury to healthcare personnel or the patient? no.Please specify if samples are : unused (before use) no.Used (during or after use) yes, during use, possible contamination by cytotoxic drugs.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.

• Brand Name: BD POSIFLUSH XS
• Type of Device: SYRING/PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; donore road; drogheda ; 8015652341
• MDR Report Key: 18117403
• MDR Text Key: 327880867
• Report Number: 9616657-2023-00048
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 3187449
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1