MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/12/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports the product is cracking and leaking during testing.

Manufacturer Narrative

An investigation was performed for the reported condition.This complaint has not been confirmed.The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.As 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 device history records (dhr) are reviewed for accuracy prior to product release.The following potential causes were identified: machine malfunction, customer misuse.An evaluation was performed to review this risk trigger and decision was to leverage on corrective and preventive action (capa) and an issue impact assessment will be requested.Once the reference number is obtained it will be attached to this complaint file.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 MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6564625
• MDR Text Key: 75094133
• Report Number: 3009211636-2017-05108
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1