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

Model Number 8888160531

Device Problem Break (1069)

Patient Problem Death (1802)

Event Date 05/29/2017

Event Type  Death  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports that a 3.5 double lumen umbilical vessel catheter snapped during length adjustment after the procedure.The baby needed surgery to remove the line left inside.The customer further reports that the patient expired.

Manufacturer Narrative

One used uvc catheter was received at cms for testing and investigation.The sample presented blood residue inside the tubing.Additionally the sample was returned inside a generic bag.A visual inspection of the catheter revealed that the tubing was broken near the distal end of the tubing.A magnified picture was taken and the sample present an irregular cut in the location.The root cause has been determined as unintentional customer misuse (excessive force, inappropriate use of cleaning agents, sharp objects, etc.).The catheter appears damaged by an instrument with sharp or rough edges during clinical use, resulting in a catheter cracked.Additionally the catheter was in use for an undetermined time without issues, which implies that the condition occurred after customer manipulation.It is important to consider that the instructions for use warn: [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] and continues, [do not use alcohol, acetone, or alcohol containing 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.Moreover, the defect found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.Per the event description, the catheter was cleaned with alcohol.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 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 (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: 6614113
• MDR Text Key: 76732875
• Report Number: 3009211636-2017-05159
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• 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
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 05/30/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other