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

Model Number	6146LL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that a mother/baby educator brought a foley set to her.The rn opened the package to set up for insertion and found the foley broken apart from the drainage bag.It came out of the package like that.The damage was identified immediately.The items never made it to the patient.
Additional Manufacturer Narrative
One decontaminated drainage bag with date code 322-0d61 was received for evaluation.The sample was visually evaluated according to the procedure.The reported issue is confirmed; the adapter was easily disconnected from the top vent.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The assembly process has been running in accordance with the approved specifications.An investigation was conducted with the multifunctional team.A gemba walk was perform in the manufacturing area, and brainstorming was done as well.As a result of this investigation, it was concluded that the most likely root cause was due to a lack of solvent in the adapter assembly with the top vent.This happens by not properly immersing the adapter in the ventrex solvent dispenser, causing the adapter not to carry enough solvent.This condition facilitated the exit of the upper breather.Documentation was created for the review of the operation and cleaning for the ventrex solvent dispenser.In addition, a quality alert was generated as an additional measure for the correct way of assembling the adapter to the top vent.We will continue to monitor the process for any adverse trends that require immediate attention.

• 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: 11845082
• Report Number: 9612030-2021-02908
• Device Sequence Number: 17279558
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Device Lot Number: 2031513064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1