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 Problem Short Fill (1575)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 prior to use, the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found to only be filled to the 7ml mark instead of the 10ml mark.The following information was provided by the initial reporter, translated from french: "health product malfunction report: "prefilled syringe in closed package but 10ml syringe filled to 7ml and presence of 3ml of air.No incidence for patient but use of duplicate material.".

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 2278656.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported defect.As neither picture samples nor physical samples were available for return, our quality engineer team was unable to complete a thorough sample analysis.Based on investigation results, an exact cause could not be determined for this reported incident.H3 other text : see h10.

Event Description

It was reported that prior to use, the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found to only be filled to the 7ml mark instead of the 10ml mark.The following information was provided by the initial reporter, translated from french: "health product malfunction report: "prefilled syringe in closed package but 10ml syringe filled to 7ml and presence of 3ml of air.No incidence for patient but use of duplicate material.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16632953
• MDR Text Key: 312206158
• Report Number: 9616657-2023-00008
• Device Sequence Number: 1
• Product Code: NGT
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2278656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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