MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH WINGS; INTERVASCULAR CATHETER

Model Number 386812

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

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 cathena¿ safety iv catheter with wings disconnection occurred and led to leakage.The following information was provided by the initial reporter, translated from spanish to english: malfunction of the connection in the operating room, causing adverse events in the patient.The anesthesia service reports that on several occasions the infusion system was disconnected from the catheter, causing drug leaks and impacting the patient.

Event Description

It was reported while using bd cathena¿ safety iv catheter with wings disconnection occurred and led to leakage.The following information was provided by the initial reporter, translated from spanish to english: malfunction of the connection in the operating room, causing adverse events in the patient.The anesthesia service reports that on several occasions the infusion system was disconnected from the catheter, causing drug leaks and impacting the patient.

Manufacturer Narrative

H6: investigation summary no photos of the defective sample or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h10.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS
• Type of Device: INTERVASCULAR 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: 15992840
• MDR Text Key: 305584312
• Report Number: 8041187-2022-00738
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868124
• UDI-Public: (01)00382903868124
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K220584
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 386812
• Device Catalogue Number: 386812
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• 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