MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA 57CM CURL CATH; DIALYSIS CATHETER

Model Number 8817278007

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Compatibility Problem (2960); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/18/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reports the nurse opened the new kit and found that the adapter was changed from opaque white to transparent yellow.Moreover, the new yellow adapter was incompatible with baxters transfer set while the old one was compatible.She found out that recently the curl catheters adapter would become loose easily when connecting with the transfer set which caused some leakage of solution.

Manufacturer Narrative

This complaint has not been confirmed.The actual sample involved in the reported incident was not returned for evaluation.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 failure investigation.A device history record (dhr) review 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 dhrs are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event.No trends or triggers have been found, therefore, a corrective or preventive action (capa) 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 in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

Event Description

The customer reports the nurse opened the new kit and found that the adapter was changed from opaque white to transparent yellow.Moreover, the new yellow adapter was incompatible with baxters transfer set while the old one was compatible.She found out that recently the curl catheters adapter would become loose easily when connecting with the transfer set which caused some leakage of solution.

• Brand Name: 57CM CURL CATH
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6038458
• MDR Text Key: 57866895
• Report Number: 3009211636-2016-00426
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817278007
• Device Catalogue Number: 8817278007
• Device Lot Number: 1514450006P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1