MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH; SYRINGE,PISTON

Catalog Number 306572

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

Patient Problem Insufficient Information (4580)

Event Date 10/04/2023

Event Type  malfunction  

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.

Event Description

It was reported that bd posiflush 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 important: in case of use, please confirm whether the samples have been used or contaminated with blood or cytotoxic drugs.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3187449.The review did not identify any possible non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, one (1) syringe sample was returned for evaluation by our quality team.Through analysis of the sample, a gap was observed between the stopper and plunger components which was outside of specification.However, based on the provided feedback (¿when screwed back in, the system doesn't hold.It is possible to inject, but not to reaspirate¿), it cannot be confirmed if this issue resulted from manufacturing.It is most likely that this incident resulted from customer misuse.The posiflush syringes are pre-filled single use syringes, intended only for flushing.Prefilled and conventional syringes have different purposes.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD POSIFLUSH
• Type of Device: SYRINGE,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) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18117424
• MDR Text Key: 327888278
• Report Number: 9616657-2023-00047
• 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