MAUDE Adverse Event Report: COVIDIEN 16FR SIL URINE METER FOLEY TRA; CATHETER, RETENTION TYPE, BALLOON

Model Number	7006LL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 the foley became disconnected at the seal at the junction of the catheter and tube connection point.
Additional Manufacturer Narrative
H 3 device evaluation: a device history record (dhr) review could not be performed because a lot number could not be provided by the customer.One decontaminated drainage bag was received.The sample was visually inspected.The reported problem was observed in the sample, the catheter was separated from the connector.A corrective and preventative action (capa) was opened to address the reported condition through a more robust investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 16FR SIL URINE METER FOLEY TRA
• 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: 10235494
• Report Number: 9612030-2020-02520
• Device Sequence Number: 18981273
• Product Code: EZL
• UDI-Device Identifier: 10884521001237
• UDI-Public: 10884521001237
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/02/2020

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: 7006LL
• Device Catalogue Number: 7006LL
• Device Lot Number: KM6428102
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1