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

Catalog Number 306572

Device Problem Material Separation (1562)

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

Event Date 03/05/2024

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd posiflush 10ml plunger pulled out of the stopper during aspiration.The following information was provided by the initial reporter, translated from french to english: when using pre-filled syringes for cvc, we do use the syringe with the plunger already pulled out, but we first purge the connections with this syringe before attaching them to the patient's cvc (central catheter).Once the connectors have been attached to the cvc, we draw saline; blood into the syringe pump barrel to eliminate any air bubbles that may be present in the cvc branches, then return the blood; saline under pulsed pressure.The defect was detected when the blood; saline was aspirated before being reinjected into the patient.The black rubber actually dislodged from the plunger when i pulled on my syringe, but remained in the syringe pump body, preventing leakage of nacl liquid as well as blood.Additional information: patient risk: possible risk of contaminating the inside of the syringe or injecting air.

Event Description

No additional information.

Manufacturer Narrative

As no physical sample, valid lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

• 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: 18990913
• MDR Text Key: 339257207
• Report Number: 9616657-2024-00012
• 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: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1