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

Model Number 8814661001

Device Problems Bent (1059); Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/12/2016.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 adapter.The customer reports the catheter adapter had a small tear in it believed to be caused from being bent too many times.As a result, fluid leaked out of the catheter adapter.The patient had gone to the clinic and had the catheter adapter replaced.Prophylactic antibiotics were given.There was no adverse event.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The device history record (dhr) review indicated that there was no quality issues associated with this failure.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to determine what could cause this event.Should the sample be 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 in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: BETA CAP ADAPTER
• Type of Device: DIALYSIS ADAPTER
• 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: 5360931
• MDR Text Key: 36061115
• Report Number: 3009211636-2016-00034
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8814661001
• Device Catalogue Number: 8814661001
• Device Lot Number: 129503X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• 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