MAUDE Adverse Event Report: COVIDIEN CATHETER PLUG W/ PROTECTOR CAP

Model Number 1600

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

Patient Problem Chemical Exposure (2570)

Event Date 02/17/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a urinary catheter plug.The customer states the catheter plug leaked, there was a hole at the tip.There was no medical intervention required.This was used on a patient that was on chemotherapy.This was caught in the recovery room and changed.The customer was concerned that the chemotherapy drug could have leaked out of the bladder and exposed the transport staff and nursing staff to the drug without protective attire and precautions if they didn't catch it in the recovery room.

Manufacturer Narrative

Submit date: 03/07/2015.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no non-conforming issues reported during the manufacture of this product for a similar condition as reported in this complaint.A sample was received for evaluation.After a visual and functional inspection was performed, the issue reported was confirmed.The connector was leaking.The most possible root causes can be due to a variation in the temperature the mold, variation of the cooling in the mold or wear in the gate mold.The process is running according to product specifications meeting quality acceptance criteria.The production personnel were notified about the reported issue.A quality alert was issued to make the production personnel aware of the reported issue.As a corrective action, the mold will be repaired and the insert gates will be modified to eliminate the high injection point generated during the current molding process.Once the insert gates are modified, the high injection point will be eliminated.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: CATHETER PLUG W/ PROTECTOR CAP
• Type of Device: CATHETER PLUG
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4579527
• MDR Text Key: 19993446
• Report Number: 9612030-2015-00021
• Device Sequence Number: 0
• Product Code: FCN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1600
• Device Catalogue Number: 1600
• Device Lot Number: 420382764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1