MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Model Number	386811
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cathena safety iv catheter leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter.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, and 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 and risk of blood exposure accident for the mer who have to clean up afterwards.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples 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 number 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.H3 other text : see h10.
Event or Problem Description
It was reported while using bd cathena safety iv catheter leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 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.
Event or Problem Description
It was reported while using bd cathena safety iv catheter leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 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: our quality engineer inspected the 5 representative sample submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there were no abnormalities or damages present.The samples underwent our internal leakage testing, and no signs of leakage were observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• 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: 16698882
• Report Number: 8041187-2023-00148
• Device Sequence Number: 19752164
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172506
• 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,Followup
• Report Date (Section B): 07/17/2023

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: 08/31/2025
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: 2238458
• 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: 05/22/2023; 07/17/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/05/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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