MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; 50382903643146

Catalog Number 364314

Device Problems Inability to Auto-Fill (1044); Difficult to Insert (1316)

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

Event Date 10/24/2022

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 when using the bd preset¿ arterial blood collection syringe the nurses found that the plunger stopper was damaged and the blood flow was slow and the amount of bleeding was small.The following information was provided by the initial reporter.The customer stated: "the nurses found that the plunger stopper was damaged and the blood flow was slow and the amount of bleeding was small.The patient was not affected.".

Event Description

It was reported when using the bd preset¿ arterial blood collection syringe the nurses found that the plunger stopper was damaged and the blood flow was slow and the amount of bleeding was small.The following information was provided by the initial reporter.The customer stated: "the nurses found that the plunger stopper was damaged and the blood flow was slow and the amount of bleeding was small.The patient was not affected.".

Manufacturer Narrative

Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure modes for deformed stopper and insufficient blood flow were observed.Additionally, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with colored water, and upon completion the indicated failure modes for deformed stopper and insufficient flow were not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure modes deformed stopper and insufficient blood flow.Bd has initiated further root cause investigation relating to the issue of deformed stopper through corrective and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
• Type of Device: 50382903643146
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15734185
• MDR Text Key: 307183127
• Report Number: 9617032-2022-01098
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022426
• 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: 07/15/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 364314
• Device Lot Number: 2091548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 07/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• 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