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

Catalog Number	386807
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 bd cathena¿ safety iv catheter the anti reflex valve does not function after insertion or connection/disconnection and there was blood leaking past the valve and out of the hub.Insertion was observed on live patient, steps for insertion were performed correctly, and as soon as the needle was pulled out of the hub, the blood would leak up by following the spring inside the catheter hub.Connection with a saline flush was performed, after disconnection, catheter leaked = valve not functioning either.Repeated this twice, with the same result.
Event or Problem Description
It was reported that bd cathena¿ safety iv catheter the anti reflex valve does not function after insertion or connection/disconnection and there was blood leaking past the valve and out of the hub.Insertion was observed on live patient, steps for insertion were performed correctly, and as soon as the needle was pulled out of the hub, the blood would leak up by following the spring inside the catheter hub.Connection with a saline flush was performed, after disconnection, catheter leaked = valve not functioning either.Repeated this twice, with the same result.
Additional Manufacturer Narrative
Investigation: 5 representative samples (unopened) were returned for investigation.The samples were subjected to blood escape time (bet) test.The samples passed the bet test, no leakage was observed.A review of past 12 months quality notification was performed and no quality notification was raised on the reported defect of leakage.No abnormality was detected during the production of the reported batch.The returned sample passed the bet test.Hence root cause could not be determined.However, there was a capa raised for blood droplet formation at the luer end of the catheter adapter (refer to capa#86125).Small id catheter tubing and small septum vents have been implemented to enhance the blood control function.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8395584
• Report Number: 8041187-2019-00205
• Device Sequence Number: 1975587
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• 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): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 386807
• Device Lot Number: 8208411
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/27/2019
• 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