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 complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the foley disconnected at the seal at the junction of the catheter and tube connection point.The foley was replaced and there was no harm to the patient.
Additional Manufacturer Narrative
The device history record could not be reviewed because the lot number provided by the customer is not a valid lot number.One sample was returned for evaluation.The sample was visually inspected.The reported problem was observed in the sample; the catheter was already separated from the connector.It is not clear how the device separated.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and 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: 10295224
• Report Number: 9612030-2020-02534
• Device Sequence Number: 11529206
• 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): 11/04/2020

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?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1