MAUDE Adverse Event Report: COVIDIEN CURITY ANT-REF 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	8944MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2020
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 at pre-insertion balloon check, sterile water would not come out from the balloon and the balloon would not deflate.
Additional Manufacturer Narrative
A device history record review could not be performed because a 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.Visual and functional evaluations were performed and the reported condition could not be confirmed; sterile water was inserted into the balloon with a syringe and the balloon then deflated normally.A root cause could not be determined as the reported issue was not confirmed.The sample was manufactured according to current product specifications, and tested under the current acceptance criteria.A production notification was performed to all personnel to ensure that they are aware on the condition reported by the customer.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: CURITY ANT-REF 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10003347
• Report Number: 9612030-2020-02456
• Device Sequence Number: 2208520
• Product Code: KNX
• UDI-Device Identifier: 10884521050648
• UDI-Public: 10884521050648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 8944MF
• Device Catalogue Number: 8944MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1