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

Model Number 8888160341

Device Problem Leak/Splash (1354)

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

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/13/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

According to the reporter, the device leaked during the procedure.

Manufacturer Narrative

An investigation of the reported condition was performed.As the lot number was identified invalid, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The actual sample involved in the reported incident had been discarded by mistake before the sample evaluation.However; one used catheter was received for decontamination.According to the submitted photo, the uvc catheter demonstrated signs of use; residues of blood.Additionally, in accordance the event description ¿the device leaking during the procedure" and per previous events of the complaint that indicates that the leak could have occurred below the strain relief, however, this cannot be confirmed since the physical sample was not tested.The returned product meets qc release specifications? the sample and photo evidence does not allow sufficient evidence to determine the acceptance condition.The sample been discarded by mistake before the evaluation.Because of the issue of the sample being discarded by mistake before the evaluation, a non-conformance report (ncr) was opened to address this issue.Manufacturing performs 100% leak testing as per procedure, which would identify this issue in the catheter assembly.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: 6948971
• MDR Text Key: 90172438
• Report Number: 3009211636-2017-05322
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1