MAUDE Adverse Event Report: COVIDIEN 2101 FOLEY CATH TRAY 16FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	2101
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
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 they couldn't remove all the liquid from the catheter's balloon.They cut the catheter above the y section but the balloon didn¿t deflate.When they did a visual inspection they realized the balloon had a deformation in the superior side.They cut the foley above the deformation which allowed the balloon to deflate.There was no patient harm.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for the evaluation.Functional inspection was performed with acceptable results.Any catheter that does not deflate in 15 minutes is considered a non-deflator, the sample received does comply with this specification.The balloon deflated in 15.51 seconds.Therefore, the reported condition is not confirmed.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: 2101 FOLEY CATH TRAY 16FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9383909
• Report Number: 9612030-2019-02368
• Device Sequence Number: 13966981
• Product Code: FCM
• UDI-Device Identifier: 10884521025554
• UDI-Public: 10884521025554
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 01/24/2020

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: 2101
• Device Catalogue Number: 2101
• Device Lot Number: 1825507964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1