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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology leaked.The following information was provided by the initial reporter: "it was reported that a blood leakage was dripping out the back of the catheter.Ahs mdip report incident or problem information ahs mdip reference number (id): 5012 date of incident (yyyy-mm-dd): (b)(6) 2020 site name/location: (b)(6).Level of harm: no apparent harm - reached patient/person, inconvenient (b)(6) optional report to (b)(6): (b)(4): no.Incident details: was using the bd cathena safety iv catheter that is bloodless as per (b)(6) policy and procedure.Once the sharp was removed blood continued to flow out of the back of catheter, dripping on to floor and my uniform and also down the patient's arm.Who was affected? patient.Device information.Device name/description: catheter iv safety winged with multiguard 18 ga x 1.25 in cathena manufacturer: (b)(4).Manufacturer code/model: 386808 serial or lot number: 8116292, supplier: the stevens company ltd supplier catalogue number: 333-386808 was the device retained? no.Investigation request: expected type of investigation: lot review, report history/trend analysis".
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.
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology leaked.The following information was provided by the initial reporter: "it was reported that a blood leakage was dripping out the back of the catheter.Ahs mdip report incident or problem information ahs mdip reference number (id): 5012 date of incident (yyyy-mm-dd): (b)(6).2020.Site name/location: cardston ems level of harm: no apparent harm - reached patient/person, inconvenient ahs optional report to cmdsnet (health canada): no incident details: was using the bd cathena safety iv catheter that is bloodless as per ahs policy and procedure.Once the sharp was removed blood continued to flow out of the back of catheter, dripping on to floor and my uniform and also down the patient's arm.Who was affected? patient device information device name/description: catheter iv safety winged with multiguard 18gax1.25in cathena manufacturer: becton dickinson canada inc manufacturer code/model: (b)(4).Serial or lot number: 8116292 supplier: the stevens company ltd supplier catalogue number: 333-386808 was the device retained? no.Investigation request expected type of investigation: lot review, report history/trend analysis".

• 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
• MDR Report Key: 10394391
• Report Number: 8041187-2020-00480
• Device Sequence Number: 19546617
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: 00382903868087
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 04/30/2021
• Device Model Number: 386808
• Device Catalogue Number: 386808
• Device Lot Number: 8116292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other