MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SYRINGE 10ML SALINE XS; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3173657.The review did not reveal any possible non-conformances during the production process that could have contributed to the reported issue.To aid in the investigation of this incident, two (2) picture samples were provided for evaluation by our quality team, allowing for a sufficient analysis of this event.The picture samples showed leakage past the stopper component.Based on the investigation results and the provided feedback, it was determined that this incident most likely resulted from customer misuse.Posiflush syringes are pre-filled single use syringes, intended for flushing only.Pre-filled 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.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush syringe 10ml saline xs leaked past the stopper with misuse.The following information was provided by the initial reporter: comment from staff member "issue: when flushing our large bore centrally inserted central catheter used for haemodialysis, sometimes the lumen needs to have an agitation which is flushing the saline in, then drawing back 2-3 times to clear any clots biofilm etc from the lumen to allow for better blood flow through the lumen during dialysis.The agitations fill the syringe with blood after the first drawing back, but what has happened is leakage of blood around the black end of the plunger that dribbles down the barrel onto the staffs gloves.See attached photos.Posiflush is being used off label to withdraw a large volume of blood more than once with the same syringe.They have been practicing this for several years and this is the first time the staff have had the leakage issue.I have spoken with a member of our clinical team who will contact the staff member to advise better clinical practice including a copy of the ifu and best practice guidelines.

• Brand Name: BD POSIFLUSH SYRINGE 10ML SALINE XS
• 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: 19095523
• MDR Text Key: 340462769
• Report Number: 9616657-2024-00013
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3173657
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1