MAUDE Adverse Event Report: COVIDIEN SWAN NECK TNCKHOFF SN TW RGHT; DIALYSIS CATHETER

Model Number 8888412015

Device Problem Contamination (1120)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Chills (2191); Injury (2348)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that the patient had intubation surgery on (b)(6).The patient then had a stomach ache after the surgery.The pain also existed when peritoneal dialysis solution was poured into the abdominal cavity, accompanied by shivering.The physician diagnosed the patient with an abdominal infection caused by bacterium on the lumen of the catheter.The patient was involved with injury.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The manufacturing lot number associated with this complaint was 313609x; released on 05/29/2013.The device history record (dhr) review indicated that there was no quality issues associated with this reported condition.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to confirm what could cause this event.Should the sample be returned in the future, this complaint will be re-opened for further investigation.More information was requested to the customer and no additional evidence was provided for this analysis.This complaint will be reopened and updated accordingly if the product sample is returned or if additional information becomes available.The swan neck tenckhoff pd manufacturing process was reviewed.The catheter is assembled manually, according to the relevant formula sheet.A 100% visual inspection is performed to detect nicks, cuts or blemishes that do not meet the specifications.This inspection takes place at the final stage of production as per the manufacturing procedure.A qa sampling inspection is also performed.In addition, this catheter is subject to a sterilization cycle.The evidence provided is not enough to relate this event to the manufacturing operations, since the product sample was not returned for evaluation.Additionally, there are a number of alternatives in the field like exposure to contaminating agents, or manipulation that may cause the reported infection.The instructions for use (ifu) indicate that infection is considered as a [potential late complication] inherent to this medical procedure and therefore it is not necessarily related with the device performance.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.Manufacturing performs 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: SWAN NECK TNCKHOFF SN TW RGHT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5268828
• MDR Text Key: 32747217
• Report Number: 3009211636-2015-00483
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/27/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 8888412015
• Device Catalogue Number: 8888412015
• Device Lot Number: 313609X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other