MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160556

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

Submit date: 05/31/17.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that they had trouble flushing the umbilicus was oozing while port was running.When we started port two, the pump repeatedly alarmed occluded patient side.The umbilical tie was loosened and then attempted to flush port one and it did the same.Previously that night we had trouble with the umbilical artery spraying blood.It did not have a catheter at the time.The artery had to be stitched but was still pulsating.The original uvc was in at 5 cm.The baby was 4500 grams so it is quite possible that between her size and the force of her blood flow, 5 cms just wasn't enough.Another nurse observed what appeared to be a hole in the line.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Submit date: 4/4/2018 a device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.One photo was provided by the customer.Visual evaluation of this photo was performed and is not possible confirm occluded with the photo.Additionally, the catheter shows signs of use (remains of blood) inside the plastic bag.The actual sample was received for analysis and investigation.The sample consisted of one dual lumen uvc catheter.The catheter came inside a generic plastic bag.Visual inspection was performed and did not reveal any problem.In order to confirm the reported defect the sample was flushed and the water passed easily through of both lumens.The reported failure has not been confirmed.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 misuse; this defect was more likely damaged during use caused due to an inappropriate manipulation by the user.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: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6600538
• MDR Text Key: 76257404
• Report Number: 3009211636-2017-05152
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2018

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
• Device Operator: Health Professional
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 219803X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 05/02/2017; 05/02/2017
• Supplement Dates FDA Received: 09/07/2017; 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4