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 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/26/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports a leak was noticed in the catheter.According to nurse the catheter had a leak that was visible about 10cm from the proximal end as a long opening.The catheter was removed immediately as leak noticed and a pic line has been introduced to the premature infant.

Manufacturer Narrative

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.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 sample, picture or video were received for testing, therefore the defect is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.Leakage is a potential failure as per product specifications.However, 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.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reports a leak was noticed in the catheter.According to nurse the catheter had a leak that was visible about 10cm from the proximal end as a long opening.The catheter was removed immediately as leak noticed and a pic line has been introduced to the premature infant.¿ a review of the device history records (dhrs) for the reported lot numbers indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.The sample consisted in one (1) used uvc catheter, which came inside a generic plastic bag.The sample presented signs of use (remains of blood).The sample received did not reference the corresponding lot number.Under water test was performed and a leak below the strain relief could be identified in the catheter.Magnified pictures were taken and in the sample a tear/hole was observed.Through visual evaluation it was observed that the catheter returned had a tear/hole below the strain relief.Due to the appearance of the catheter received, it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use, resulting in a catheter leakage.Additionally the catheter was in use for a period of time without issues, which implies that the event occurred after customer manipulation.Pressure testing is conducted for all catheters.The tear/hole found during sample evaluation would have been detected in this step.The reported issue occurred after being in use in a patient.Based on the available information, it can be concluded that product was manufactured according to specifications.The customer reported issue most likely occurred during use caused due to an inappropriate manipulation by the user.The reported customer complaint is confirmed.The probable root cause is customer misuse.This complaint will be used for 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 20101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7297686
• MDR Text Key: 101011626
• Report Number: 3009211636-2018-00061
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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: 1633500149,1620900121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 1