MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that bd posiflush¿ pre-filled saline syringe had a difficult to move plunger.The following information was provided by the initial reporter: "when injecting nacl, blocking at the plunger.¿.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ pre-filled saline syringe had a difficult to move plunger.The following information was provided by the initial reporter: "when injecting nacl, blocking at the plunger.¿.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 2/16/2022.H.6.Investigation: three syringe samples were returned for evaluation by our quality engineer team.Two of the syringes were empty with the solution fully ejected and the third syringe had the plunger rod depressed halfway down the barrel.When attempting to move the plunger rod back and forth within the barrel, there were no restrictions in movement noticed in the first two syringes.The third syringe showed a minor restriction at the start of movement, but then began to move freely.A device history record review was completed for provided material number 306572 and lot number 1244122.The review revealed on non-conformance during the production process related to dry barrels, which could have contributed to the defect of difficult plunger movement.However, the defective material was identified and scrapped after detection.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• 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: 13424273
• MDR Text Key: 286151962
• Report Number: 9616657-2022-00002
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 1244122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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