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

Catalog Number 306572

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that bd posiflush syringe leaks.The following information was provided by the initial reporter: a home dialysis patient has reported to us that the plunger isn¿t tight enough and saline as well as blood go everywhere when she uses it on her neckline to wash out the line.It¿s dangerous and it¿s become every single time.50% of all syringes.The patient confirmed that as a result of this issue, she has not had any ill effects, or required to be hospitalised.Our records show 1920 of this lot distributed, no other issues , nor any issues for product on our record.We¿ve taken a couple of syringes out of three lots in our store (not same lot) and they are perfect, and it¿s noted that you apply a threaded cover, which would highlight any problems.No sample has been provided, so the issue could be the ¿other¿ connecting device (unknown).

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.B3.The date received by manufacturer has been used for this field.E1.Address too long for e tab: (b)(6).

Event Description

Response received (18/12/2023).Could you please provide a date of event? = various, nonspecific enquiry.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? = no injury reported.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 2306330.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.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 SYRINGE
• 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: 18489278
• MDR Text Key: 332995543
• Report Number: 9616657-2023-00058
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• 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: Foreign,Company Representative,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: Lay User/Patient
• Device Catalogue Number: 306572
• Device Lot Number: 2306330
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1