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

Model Number	386812
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8041187-2022-00738
• Device Sequence Number: 14974552
• Product Code: FOZ
• UDI-Device Identifier: 00382903868124
• UDI-Public: (01)00382903868124
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown