MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PRO SAFETY ARTERIAL CATHETER; INTRAVASCULAR CATHETER

Catalog Number 380073

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The reported lot # 1110435 was not found for the reported catalog # 380073.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd¿ pro safety arterial catheter had an improperly functioning flow switch.The following information was provided by the initial reporter: "the operators complain that the flow switch valve is released and it is no longer possible to re-screw it to the luer lock, also after a few uses the valve remains completely open".

Event Description

It was reported bd¿ pro safety arterial catheter had an improperly functioning flow switch.The following information was provided by the initial reporter: "the operators complain that the flow switch valve is released and it is no longer possible to re-screw it to the luer lock, also after a few uses the valve remains completely open".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 22-mar-2022.H6: investigation summary.A device history review was conducted for lot number 1110435.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample was returned to our facility to aid in our investigation.Functional testing was performed both on the returned unit and on the available retention samples for the affected lot.The results show that the tested units performed within product specifications for both the retained and returned units.Unfortunately, without the ability to replicate the reported failure mode our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

• Brand Name: BD¿ PRO SAFETY ARTERIAL CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13514529
• MDR Text Key: 287350012
• Report Number: 2243072-2022-00190
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/24/2022

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 Catalogue Number: 380073
• Device Lot Number: 1110435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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