MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 381323

Device Problem Defective Device (2588)

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

Event Date 04/27/2022

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 that the bd insyte-w¿ iv catheter experienced catheter damage. The following information was provided by the initial reporter: it was reported that the catheter was damaged.

• Brand Name: BD INSYTE-W¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14830961
• Report Number: 8041187-2022-00335
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: 00382903813230
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151698
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 381323
• Device Lot Number: 1274178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG