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

Catalog Number 306572

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from german to english: there are black particles on the syringe plunger.Foreign bodies or impurities can enter the bloodstream!.

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.

Manufacturer Narrative

To aid in the investigation of this issue, one (1) syringe sample was returned for evaluation by our quality team.Through examination of the sample, the syringe/plunger was found to have embedded foreign matter.This type of defect most likely occurred during the molding process.A device history record review was completed for provided material number 306572 and lot number 2208047.There was one possible non-conformance identified which could have contributed to this reported incident.The non-conformance was related to threads on the plunger rod, which was discovered during the startup checks.The manufacturing technician was notified, and the affected product and manufacturing components were purged accordingly.Based on the investigation conclusions, it is likely that the molding machine was not purged for long enough, resulting in contaminated material.At this time, further action has not been determined necessary, as this is the first report received for this type of defect for this lot.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.There are black particles on the syringe plunger.Foreign bodies or impurities can enter the bloodstream.

• Brand Name: BD POSIFLUSH¿ NORMAL 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17577826
• MDR Text Key: 321632755
• Report Number: 9616657-2023-00034
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2208047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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