MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problems Failure to Deliver (2338); Physical Resistance/Sticking (4012)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 that 4 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% had difficult plunger movement during use, getting stuck with 3 - 4 ml of saline left.The following information was provided by the initial reporter: "patient reported she is having a issue with one box of posiflush.There have been 4 syringes were the plunge got stuck with 43ml left.Customer confirmed this should be 3 to 4 ml left.".

Event Description

No additional information provided.306572 10ml 0.9% flush syringe saline bd/bn 3054816.Patient reported she is having a issue with one box of posiflush.There have been 4 syringes were the plunge got stuck with 43ml left.On 31-august-2023 per customer: sorry for the confusion, yes this meant to say 3 to 4 ml left.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3054816.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.As samples were unavailable for return, a thorough sample analysis could not be completed.Based on the investigation results, an exact cause could not be determined for this reported incident.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¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17687121
• MDR Text Key: 322721360
• Report Number: 9616657-2023-00036
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 3054816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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