MAUDE Adverse Event Report: COVIDIEN FOLEY TRAY SILICON DRAIN BAG 16FR; CATHETER, RETENTION TYPE, BALLOON

Model Number	6146LL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that they had difficulty removing the catheter from the port.The catheter ripped and broke into two pieces.One part was still connected to the sample port.
Additional Manufacturer Narrative
Evaluation summary a review of the device history record (dhr) could not be conducted because a lot number was not provided.One decontaminated sample with the date code unknown was received for evaluation.After visual inspection it was observed that there was damage to the catheter.The reported condition was confirmed the adapter on the device had been changed for a redesign of the sample port connector to increase the disconnection force between the adapter and the catheter, as well as to minimize the size of the sample port.Because of this, the new adapter on the connection side has 2 steps, it cannot be assembled with the top vent.Due to problems with the new adapter, the manufacturing site went back to manufacturing the device with the old adapter.

• Brand Name: FOLEY TRAY SILICON DRAIN BAG 16FR
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8671422
• Report Number: 9612030-2019-02194
• Device Sequence Number: 291539
• Product Code: EZL
• UDI-Device Identifier: 10884521015500
• UDI-Public: 10884521015500
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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
• Operator of Device: No Information
• Device Model Number: 6146LL
• Device Catalogue Number: 6146LL
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 09/12/2019
• Patient Sequence Number: 1