MAUDE Adverse Event Report: COVIDIEN BETA CAP ADAPTER; DIALYSIS CATHETER

Model Number 8814661001

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 states that there was drain fluid leaking and there was a hole in the catheter at the barbed side of the catheter on the side of the adapter that is closest to the patient.This looks like a slice from the first barb of the adapter.The patient was brought to the unit, the catheter was repaired and treated for gross contamination with antibiotics in an effort to prevent peritonitis.The hole was repaired with a new adapter and extension set.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Since the sample was not returned, there is not enough evidence to determine what could cause this event.However the pfmea was reviewed in order to identify the possible root causes for the failure leaking.The following potential failures were identified in the pfmea or in addition to this document: in-process inspection not performed, defective material, malfunction, misuse and/or inattention.With the available information it is not possible to confirm a root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Corrective actions were not required.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: BETA CAP ADAPTER
• 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 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5088784
• MDR Text Key: 26473605
• Report Number: 3009211636-2015-00368
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/08/2015

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: 8814661001
• Device Catalogue Number: 8814661001
• Device Lot Number: 329704X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1