MAUDE Adverse Event Report: COVIDIEN BETA CAP ADAPTER

Model Number 8814661001

Device Problems Contamination (1120); Fluid/Blood Leak (1250); Scratched Material (3020); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that the customer had an issue with a beta cap adapter.The customer states that the adapter barb damages the catheter where it meets catheter and causes a tear, leak, and contamination.The patient required antibiotics to prevent infection.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The manufacturing lot number associated with this complaint was 020439.The device history record (dhr) review indicated that there was no quality issues associated with this defect mode.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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 information will be utilized for tracking and trending purposes to determine the need for corrective action.

• Brand Name: BETA CAP ADAPTER
• Type of Device: BETA CAP ADAPTER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela NY 12809 ; CS 12809
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 3844693
• MDR Text Key: 4659203
• Report Number: 1317749-2014-00226
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8814661001
• Device Catalogue Number: 8814661001
• Device Lot Number: 020439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2014
• Date Manufacturer Received: 10/09/2014
• 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): Required Intervention