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

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/20/2017.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 that there was leakage somewhere on the body of the catheter.

Manufacturer Narrative

Submission date: (b)(6) 2018.An investigation was performed for the reported customer complaint: ¿the customer reported that there was leakage somewhere on the body of the catheter.¿ a review of the device history record (dhr) for lot no.1618800116 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.A sample was returned for evaluation.Visual inspection of the returned catheter noted no abnormalities.Functional testing was performed.The catheter was submerged into a water bath.The end was clamped and a syringe was used to inject air to observe leakage.No air bubbles were present.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation of the reported condition was performed.A device history record (dhr) review revealed no discrepancies that may have contributed to this reported condition.All quality assurance testing performed during manufacturing process was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met all 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 investigation.No probable root cause was determined since no sample, picture or video were received for investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.Therefore, the reported condition is not confirmed.A corrective or preventive action (capa) 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 non-conforming 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: 7045526
• MDR Text Key: 92525037
• Report Number: 3009211636-2017-05357
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1618800116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1