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

Model Number	386808
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported, that the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology tubing burst, during the injection and leaked as a result.The following information was provided by the initial reporter, translated from french: "the anti-reflux valve causes an overpressure during the injections at the ct (injection at 4-5 cc/sec) causing: a leak on the 3-way valve.Explosion of the tubing.Poor scanner injection, making diagnosis difficult.Risk of blood exposure accident for the mer who have to clean up afterwards.This problem occurs with most of the catheters used.It does not seem to affect only one batch.Consequences: leak on the 3-way valve.Explosion of the tubing.Poor scanner injection, making diagnosis difficult.Risk of blood exposure accident for the mer who have to clean up afterwards".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-apr-2023.H6: investigation summary no photos or samples of the reported batch number were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.10 samples of unreported batches were returned and were tested for the reported defect.After leakage testing, no leakage was detected on any of the samples.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology tubing burst during the injection and leaked as a result.The following information was provided by the initial reporter, translated from french: "the anti-reflux valve causes an overpressure during the injections at the ct (injection at 4-5 cc/sec) causing: a leak on the 3-way valve; explosion of the tubing; poor scanner injection making diagnosis difficult; risk of blood exposure accident for the mer who have to clean up afterwards this problem occurs with most of the catheters used, it does not seem to affect only one batch.Consequences : leak on the 3-way valve; explosion of the tubing; poor scanner injection making diagnosis difficult; risk of blood exposure accident for the mer who have to clean up afterwards.".

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16746033
• Report Number: 8041187-2023-00159
• Device Sequence Number: 8627208
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: 00382903868087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/24/2023

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 Expiration Date: 09/30/2025
• Device Model Number: 386808
• Device Catalogue Number: 386808
• Device Lot Number: 2274704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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