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

Catalog Number 380074

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that the catheter kinks easily during use of bd pro safety arterial catheter.No patient impact reported.The following information was provided by the initial reporter, translated from (b)(6) to english: kinks off very easily.

Manufacturer Narrative

In this mdr, bd corporate headquarters in (b)(4) has been listed in sections and the franklin lakes fda registration number has been used for the manufacture report number as deltamed is an oem manufacturing site.Date of event is unknown.The date received by manufacturer has been used for this field.An invalid lot # (1180115) was provided.Medical device expiration date: unknown.Device manufacture date: unknown.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 catheter kinks easily during use of bd pro safety arterial catheter.No patient impact reported.The following information was provided by the initial reporter, translated from dutch to english: kinks off very easily.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 1180115.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD PRO SAFETY ARTERIAL CATHETER
• Type of Device: ARTERIAL 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: 15299212
• MDR Text Key: 305518862
• Report Number: 2243072-2022-01404
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 380074
• Device Lot Number: UNKNOWN - SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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