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

Catalog Number 306572

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.This mdr represents "the same thing happened to a colleague this morning".

Event Description

It was reported that bd posiflush syringe stopper separated from the plunger.The following information was provided by the initial reporter, translated from french to english: during an attempt to unblock an implantable chamber, the piston of se bd posiflush10ml got stuck in my hands: it dislodged from the membrane inside the syringe.Nothing for the patient at the time, but it could have happened.For me as a carer, i had to take another se, interrupt care; the same thing happened to a colleague this morning.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3285240.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.As neither physical samples nor picture samples were available, a thorough sample analysis could not be completed at this time.Based on the investigation results, an exact cause could not be determined for this incident.This is the first report received for this type of defect on material 306572 and batch 3285240.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

No additional information.

• Brand Name: BD POSIFLUSH
• 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: 18622357
• MDR Text Key: 334667289
• Report Number: 9616657-2024-00004
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: 3285240
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1