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

Catalog Number 306546

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ normal saline syringes, the plunger was difficult to move.This occurred 5 times.2 of 5 related files.There was no report of patient impact.The following information was provided by the initial reporter: we have noticed several saline flushes (bd 0.9% sodium chloride injection) that seem to 'jam up' while being used.Only 2-5 ml will push then the plunger stops working.It can lead to questioning of the iv patency and possible additional iv sticks for the patient if the nurse thinks the iv is bad when it is really the flush.We have disconnected the flush and it still is hard or impossible to depress the plunger.We have had at least 5 reports of defective flushes.

Manufacturer Narrative

To aid in the investigation of this issue, two (2) physical samples were returned for evaluation by our quality engineer team.The two samples had been removed from their flow wrap testing, disassembled, and emptied; therefore, we were unable to confirm the reported defect.Although we could not confirm the issue through the samples, it is possible that this incident resulted from a faulty thermocouple.The thermocouple controls the dispersion of silicone in the syringe barrel.The faulty thermocouple in turn led to intermittent defects which were not detected during the in-process checks.A review of the manufacturing execution system (mes) shows a report of faulty thermocouple during the manufacture of this lot; however, the faulty thermocouple has since been replaced.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¿ NORMAL SALINE 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17886022
• MDR Text Key: 325086545
• Report Number: 9616657-2023-00045
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3103219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1