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

Model Number 8888160119

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/04/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the umbilical vessel catheter leaked just below the hub where the catheter is joined.The customer further reports that there was no patient harm.

Manufacturer Narrative

An investigation of the reported condition was performed.Since no lot number was identified, a manufacturing device history 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 customer returned the sample for evaluation.The sample consisted of two used single uvc catheters inside a generic plastic bag.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 1, a tear was observed.The sample 2 was tested under water and a leak was observed; it has cut below strain relief.The reported condition was confirmed.The uvc catheter showed signs of being used in a patient.It is important to consider that the instructions for use warning: exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use clamps on umbilical vessel catheters] and continues, do not use alcohol, acetone, or alcohol contai ning antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter.There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources or manipulation per se, that may lead to tubing tear.Based on the available information this potential cause could not be discarded.Based on the available information, it can be concluded that product was manufactured according to specifications.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.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined time; therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to an inappropriate manipulation by the user.It must be noted that in-process controls (su ch as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) 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 820 calle #2 zona fra; alajuela,cr 20101
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona fra; alajuela,cr 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6767705
• MDR Text Key: 81837695
• Report Number: 3009211636-2017-05253
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160119
• Device Catalogue Number: 8888160119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1