MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145017P

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states there is a hole in the catheter between the hub and the silicon extension.The catheter was removed and replaced with another catheter.There was no harm to the patient.

Manufacturer Narrative

Since no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.One used palindrome catheter was received for analysis and investigation.The catheter was returned inside a plastic bag and it presented signs of use.An underwater test was performed and a leak below the hub at the shaft of the catheter could be identified.An ishikawa diagram was used to determine the potential causes for this event.Multiple components are used in the manufacture of this product.Components properties are tested by the suppliers and there are controls in place in the manufacturing site to prevent non-conforming material from being used.Through visual evaluation it was observed that the catheter was cut at the shaft of the catheter.Due to the appearance of the catheter received it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use or use of cleaning agents, resulting in a catheter leakage.Additionally the catheter was in use for an undetermined time without issues, which implies that the issue occurred after customer manipulation.It is important to consider that the instructions for use (ifu) warn that clamping the catheter repeatedly in the same spot could weaken the tubing and to change the position of the clamp regularly to prolong the life of the tubing.It states to avoid clamping near the adapter and hub and exercise caution when using sharp instruments near the catheter.The ifu warns that the catheter tubing can tear when subjected to nicks, excessive force, or rough edges and not to use acetone on any part of the catheter.Moreover, the reported condition found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.The reported condition has been confirmed.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 damaged during use caused due to an inappropriate manipulation by the user.No triggers or trends were identified.No further actions are required.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states there is a hole in the catheter between the hub and the silicon extension.The catheter was removed and replaced with another catheter.There was no harm to the patient.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: diane matheus ; 15 hampshire street; mansfield, MA 02048 ; 5085421480
• MDR Report Key: 6756839
• MDR Text Key: 81495457
• Report Number: 3009211636-2017-05244
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123196
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145017P
• Device Catalogue Number: 8888145017P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1