MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH-SP PRE-FILLED SYRINGES; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.E4.The initial reporter also notified the fda on 3 nov 2023.Medwatch report is mw5147833.

Event Description

It was reported that bd posiflush-sp pre-filled syringes luer tips are bent.The following information was provided by the initial reporter: two syringes from the same lot were found in the supply cart with bent tips (see photos).Other syringes remaining from this lot number were not impacted by this issue.

Manufacturer Narrative

A device history record review was completed for provided material number 306546 and lot number 3166957.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, two (2) picture samples were received for evaluation by our quality team.Through examination of the pictures, damaged syringe tip was identified.It is most likely that the syringe tip damage resulted from the grippers in the syringe fill process.This type of damage could occur intermittently and therefore, go undetected by the in-process inspections.This is the first report received for this defect on material 306546 and lot 3166957.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.

Event Description

What was the patient outcome? a.The reported flushes did not reach the patient.Was there a delay of, or change in, the course of treatment due to the event? a.The delay in care was inconsequential.Did the issue happen during patient use? if yes, was there any injury? a.No.

• Brand Name: BD POSIFLUSH-SP PRE-FILLED SYRINGES
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• 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: 18499589
• MDR Text Key: 333195613
• Report Number: 9616657-2024-00001
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3166957
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1