MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, PERITONEAL DIALYSIS, SINGLE USE

Model Number UNK DY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2017/may/30.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

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states 9 weeks after insertion the patient returned to the facility for dialysis and the nurse found the catheter was freely moving in and out of the entry site.

Manufacturer Narrative

An investigation was performed.Since no lot number was identified, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be performed.However, all dhrs 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 a sample, picture or video were not received for testing; therefore the reported issue is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.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.

Event Description

The customer states 9 weeks after insertion the patient returned to the facility for dialysis and the nurse found the catheter was freely moving in and out of the entry site.

Manufacturer Narrative

The line was discarded by the patient/renal nurses since it is a single use item.No photos available.The cuff was completely out with no signs of fibrosis to the patient's tissue after 6 weeks sutured.No tract infections and sutures removed at 6 weeks.Patient 3: female, (b)(6), right jugular line - 23cms, line slipped out in the 9 weeks.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states 9 weeks after insertion the patient returned to the facility for dialysis and the nurse found the catheter was freely moving in and out of the entry site.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, PERITONEAL DIALYSIS, SINGLE USE
• 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: 6597541
• MDR Text Key: 76152527
• Report Number: 3009211636-2017-05142
• Device Sequence Number: 1
• Product Code: FKO
• Combination Product (y/n): N
• Reporter Country Code: MT
• 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,Followup,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK DY
• Device Catalogue Number: UNK DY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR