MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Material Separation (1562)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

E.1 initial reporter phone #: (b)(6).H3.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¿ saline xs 10 ml stopper separation from plunger.The following information was provided by the initial reporter, translated from french to english: a saline syringe with a maladjusted plunger; thus, it was separated in its original packaging.

Manufacturer Narrative

H6: investigation summary to aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality engineer team.Through examination of the picture, the plunger component was observed separate from the syringe barrel/stopper.A device history record review was completed for provided material number 306572 and lot number 2256675.The review did reveal one non-conformance during the production process that could have contributed to this incident.Although the non-conformance was resolved at the time of detection, it is possible that a limited amount of material went undetected prior to the containment process.Therefore, this incident most likely resulted from a damaged spring in the gripper of the plunger rod machine.The spring was replaced during production and the issue has been resolved.

Event Description

It was reported that the bd¿ posiflush¿ saline xs 10 ml stopper separation from plunger.The following information was provided by the initial reporter, translated from french to english: a saline syringe with a maladjusted plunger; thus, it was separated in its original packaging.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17221399
• MDR Text Key: 318495945
• Report Number: 9616657-2023-00014
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2256675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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