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

Catalog Number 381337

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Foreign Body In Patient (2687)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte-w¿ peripheral venous catheter the catheter kinked and separated.The following information was provided by the initial reporter: it was reported by the customer that the catheter was at first believed to be kinked, then upon further review it was completely broken off still in the vessel.

• Brand Name: BD INSYTE-W¿ PERIPHERAL VENOUS 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: 15704478
• MDR Text Key: 302762182
• Report Number: 8041187-2022-00632
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813377
• UDI-Public: 00382903813377
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381337
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• 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
• Patient Outcome(s): Required Intervention