MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/2/2018. 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. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the catheter leaking from the area near the connection hub/proximal end.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported condition. During the manufacturing process, all quality assurance testing was completed with acceptable results. 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. Manufacturing performs 100% leak testing as per procedure which would identify this issue as a part of the catheter assembly process. 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. The 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 the catheter leaking from the area near the connection hub/proximal end. ¿ a review of the device history record (dhr) for lot no. 1626500197 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. Multiple components are used in the manufacture of this product. 100% of the catheters produced are submitted to a pressure test which would identify this issue in the catheter. Sample was received for evaluation. One (1) used uvc catheter with two (2) syringes and a set of tubes, were returned inside a generic plastic bag and present signs of use (possibly remains of blood). Visual inspection was performed. The catheter was observed with a tear/hole below the strain relief that could have generated the leak. Potential causes of the reported condition include defective material, operator failed to follow process or inspection procedures, user did not follow instructions, machine malfunction, or measurement specifications. Information is insufficient to determine whether these scenarios occurred. 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 defect occurred after customer manipulation. The reported condition was confirmed. Based on the available information, it can be concluded that product was manufactured according to specifications. Therefore, the most probable root cause can be considered as misuse. 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 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: 7310289
• MDR Text Key: 101402578
• Report Number: 3009211636-2018-00068
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/22/2021
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1626500197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown