MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160333

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/19/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter.The customer states that on (b)(6) 2016 at 0800 hours, a premature infant had an umbilical catheter inserted into an umbilical artery to the depth of 11cm.Fluids were infused through the catheter.On (b)(6) 2016, the infusion line was changed at 0630 hours for the umbilical arterial catheter.There was leakage noticed near the catheter hub.The bed linen was soaked with blood lines from the line.It was immediately reviewed and the catheter was removed at 0615 hours.On (b)(6) 2016, the catheter was tested with tap water and water was visibly squirting out near the catheter hub.

Manufacturer Narrative

One video was provided by the customer and a visual evaluation of this video was performed.The video demonstrated that the clinician was holding the uvc catheter and it was not in the patient body; the catheter was flushed with an unknown solution, and a leak occurred just below the strain relief.Subsequently, the physical sample was received at plant for evaluation; it consisted in 1 uvc catheter that came inside a generic plastic bag and showed signs of use and manipulation (blood residues).The visual inspection did not show any identifiable defects.An under water test was performed and a leak was identified below the strain relief of the catheter, however the origin of the leak could not be observed with a naked eye.Magnified pictures were taken and a cut below the strain relief was observed.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for a period of time; therefore the most probable root cause can be considered as unintentional misuse; this defect was more likely damaged during use caused due to an inappropriate manipulation of the product causing it to leak.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6187044
• MDR Text Key: 63187479
• Report Number: 3009211636-2016-00505
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1