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 Contamination (1120)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger had foreign matter on it.The following information was provided by the initial reporter: "syringe plunger is dirty, it seems to be polluted.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: a device history record review was completed for provided material number 306572 and lot number 0021182.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.To aid in the investigation of this issue, both picture samples and the affected physical sample were returned for evaluation by our quality engineer team.Through examination of the sample, embedded foreign matter was observed on the plunger rod component of the syringe within the unopened blister packaging.The physical sample was sent for fourier-transform infrared (ftir) spectroscopy, in order to identify the foreign material.The ftir analysis confirmed that the foreign material was composed of olefin fiber or a polyolefin polymer material.It has been determined that the foreign material most likely resulted due to a stoppage in the molding machinery which allowed for degradation of the material at the tip.Capa#3251946 was initiated for this issue.H3 other text : see h.10.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger had foreign matter on it.The following information was provided by the initial reporter: "syringe plunger is dirty, it seems to be polluted.".

• 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: 14215117
• MDR Text Key: 290290369
• Report Number: 9616657-2022-00012
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 0021182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2020
• 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