MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported the uvc was inserted on (b)(6).According to the nurse coordinator, uvc fluids were infusing without any issues until (b)(6) at 0530 when the rn observed that the infant¿s bed was wet.Fluid was noted dripping from the catheter and not the iv tubing.The catheter appeared to have a hole.The nurse practitioner was notified by the rn and the catheter was removed.
Additional Manufacturer Narrative
The device history record was no able to be reviewed as there was no lot number provided.A sample consisting of one used catheter, which came inside a generic plastic bag was received for evaluation.The sample demonstrated a leak during testing.The reported issue was confirmed.Additionally, the catheter showed signs of use (residues of blood).Underwater testing was performed, and a leak was detected below the strain relief in the catheter.During the underwater test, the catheter was bubbling.It¿s important to consider that the instructions for user warn ¿do not use sharp clamp or instrument to handle the catheter since even a minor cut could tear or break the catheter.Do not stretch catheter, too much tension could tear the catheter.Do not use alcohol or acetone-based skin preparations, adhesive enhancers, or solutions directly on the catheter.Based on the available information and sample this cause could not be discarded.It can be concluded that the product was manufactured according to specifications; therefore, the most probable root cause could occur during use if manipulated for fit or patient movement.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9297026
• Report Number: 3009211636-2019-00678
• Device Sequence Number: 14162393
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: No Information
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1