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

Model Number 6146LL

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 08/28/2019

Event Type  Injury  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that upon removal of catheter, about 3/4 inch of the end of the catheter was missing.Additional information received from the customer stated that the catheter was in place less than 24 hours and removed after delivery.It was used on a female patient.A flex cystoscopy procedure was performed to look for the missing end of the catheter.No missing end of the catheter was found inside the patient.The patient is currently doing well with no issues.

Manufacturer Narrative

A device history record review could not be performed because a valid cardinal health lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample was received at the manufacturing site for the investigation.The sample received was damaged, as a result testing could not be completed to confirm the reported issue.A review of the manufacturing process of the drainage bag has concluded that the reported condition could not have been generated in the production line at cardinal health.The catheter is a purchased component provided by an external supplier.The catheter arrives inside of a sleeve prior to assembling it with the pvc tubing.The operator does not remove the sleeve during this process.The same process is followed in the workstation (sub-assembly area) where the catheter is assembled with the adapter, again the sleeve is not removed.Therefore, the reported condition could not be generated during the manufacturing process of the drainage bag.A complaint notification was sent to the external supplier along with the sample to initiate the investigation of the root cause of the reported condition and request corrective actions.This complaint will be used for qa tracking and trending purposes.

• Brand Name: FOLEY TRAY SILICON DRAIN BAG 16FR
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9105791
• MDR Text Key: 159673466
• Report Number: 9612030-2019-02273
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884521015500
• UDI-Public: 10884521015500
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6146LL
• Device Catalogue Number: 6146LL
• Device Lot Number: 5114268
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 02/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other