MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306573

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/05/2022

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¿ sp pre-filled flush syringe nacl 0.9% stopper separated from the plunger.The following information was provided by the initial reporter: "disconnect between plunger and stopper".

Event Description

It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% stopper separated from the plunger.The following information was provided by the initial reporter: "disconnect between plunger and stopper".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes, d10: returned to manufacturer on: 2022-jan-17.Investigation summary: to aid in the investigation of this issue, a picture and a physical sample were returned for evaluation by our quality engineer team.Through examination of the sample, the plunger rod was observed broken and separated from the barrel.A device history record review was completed for provided material number 306573 and lot number 1005958.There were several second samplings performed during the production process due to an issue with plunger rod breakage.However, as the second samplings and inspections were found to have correct results, no quality notifications were opened for the issue.As this incident has occurred, we can determine that although the second samplings were accepted per the acceptance criteria, an isolated sample went to the market.The damaged plunger most likely resulted during the plunger assembly process.If the machine is not well adjusted, the pressure used to assemble the components may cause damage to the plunger rod and the plunger rod can become loose from the barrel after visual inspection.This is a very unusual circumstance.The primary packaging process is inspected on a regular basis under our quality assurance procedures.The assembly machines vision system is also challenged for detection and rejection of plunger rod assembly issues.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.

• Brand Name: BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13338065
• MDR Text Key: 285404268
• Report Number: 3002682307-2022-00012
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 306573
• Device Lot Number: 1005958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2021
• 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