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 09/13/2022

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found with the incorrect prefill of 3ml before use.The following information was provided by the initial reporter, translated from french: "before purging the syringe, the nurse realized that it was only filled with 3ml.The material was however well packed.".

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 05-oct-2022.H6: investigation summary a device history record review was completed for provided material number 306572 and lot number 2166764.The review did not reveal any non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, two (2) picture samples and one (1) physical sample were returned for evaluation by our quality engineer team.Through examination of the samples, the defect of incorrect fill was observed.The most probable cause for this instance of incorrect fill is a sink mark located in the luer component of the barrel.The applicable molding cavities related to this component have been replaced.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found with the incorrect prefill of 3ml before use.The following information was provided by the initial reporter, translated from french: "before purging the syringe, the nurse realized that it was only filled with 3ml.The material was however well packed.".

• 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 ; 8015296192
• MDR Report Key: 15545150
• MDR Text Key: 306642915
• Report Number: 9616657-2022-00034
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

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: 2166764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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