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

Model Number	386804
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd cathena¿ safety iv catheter, the device experienced leakage (blood) from the flashback chamber.The following information was provided by the initial reporter.The customer stated: the user clinician reports that during the insertion of the catheter (bdcathena multiguard 20g) the multiguard system did not work causing the blood to leak.The sewed blood has partially dirtied the operator's hand.The only impact occurred on the operator who had his hand stained with blood.
Additional Manufacturer Narrative
H.6.Investigation: 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 h.10.
Event or Problem Description
It was reported when using the bd cathena¿ safety iv catheter, the device experienced leakage (blood) from the flashback chamber.The following information was provided by the initial reporter.The customer stated: the user clinician reports that during the insertion of the catheter (bdcathena multiguard 20g) the multiguard system did not work causing the blood to leak.The sewed blood has partially dirtied the operator's hand.The only impact occurred on the operator who had his hand stained with blood.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12746559
• Report Number: 8041187-2021-00946
• Device Sequence Number: 4852592
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 11/18/2021

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: 02/28/2023
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 0059299
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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