MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; INTRAVASCULAR CATHETER

Model Number 306546

Device Problems Difficult to Flush (1251); Material Separation (1562)

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced difficult plunger movement, and stopper separation from plunger.The following information was provided by the initial reporter: this lot is really really hard to flush ¿ the plunger seems rather stiff ¿ we checked the other lot and it seems to only be this one.Also said plunger handle comes detached from black plunger.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: a device history record review was completed for provided material number 306546 and lot number 1244145.The review revealed non-conformances that could have contributed to the reported incident of plunger movement difficult.There was an issue with one of the siliconization units during the manufacture of lot number 1244145 which could have resulted in an incorrect dose of silicon applied to the barrel component.Although this issue was resolved at the time of occurrence, it is possible that there was limited affected product outside of the contained material.Regarding the issue of the plunger detaching from the stopper component, the most probable cause is misuse.Posiflush syringes are pre-filled single use syringes intended for flushing only.Prefilled and conventional syringes have different purposes.Further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced difficult plunger movement, and stopper separation from plunger.The following information was provided by the initial reporter: this lot is really really hard to flush ¿ the plunger seems rather stiff ¿ we checked the other lot and it seems to only be this one.Also said plunger handle comes detached from black plunger.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• 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: 14961117
• MDR Text Key: 299698609
• Report Number: 9616657-2022-00022
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1244145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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