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

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/24/17.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the following complaint regarding an infant delivered at 28 weeks and 6 days: the patient was stabilized with cpap initiation.An umbilical arterial (uac) and venous (uvc) catheters were inserted at delivery.The uac was a 3.5 fr.Single lumen inserted by the neonatal nurse practitioner (nnp).Approximately 1 hour after insertion and approximately 10 minutes after starting a premasol infusion, the uac was noted to be leaking from a hole at the end near the hub.On inspection, the np noted a "crack" in the catheter.The line was clamped and then removed.

Manufacturer Narrative

A device history review revealed no discrepancies that may have contributed to a complaint of this reported condition.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.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no samples, picture or video were received for testing, therefore the reported condition is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.Manufacturing performs 100% leak testing as per procedure which would identify this issue in the catheter assembly.No trends or triggers have been found therefore, a corrective or preventive action is not deemed necessary at this time.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 performed in the plant) 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: 6973975
• MDR Text Key: 90749628
• Report Number: 3009211636-2017-05335
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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
• Device Lot Number: 1715200155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 202 DA
• Patient Weight: 1