MAUDE Adverse Event Report: COVIDIEN PRECISION PRM 16FR CATH SECURE; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	PP16XSD
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
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.  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 when all the water was removed from the balloon, the balloon of the foley didn't deflate completely.There was no patient harm reported.
Event or Problem Description
The customer reported that when all the water was removed from the balloon, the balloon of the foley didn't deflate completely.Additional information was provided by the customer and it was stated that the issue was identified after the procedure, there was no delay in the procedure and no second device was used.The customer further confirmed that there was no patient harm reported.
Additional Manufacturer Narrative
Section b3 event date field has been corrected.Section b5 has been updated to include additional information.

• Brand Name: PRECISION PRM 16FR CATH SECURE
• 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: 10733754
• Report Number: 9612030-2020-02674
• Device Sequence Number: 19274440
• Product Code: KNX
• UDI-Device Identifier: 10884521029705
• UDI-Public: 10884521029705
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/11/2021

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: PP16XSD
• Device Catalogue Number: PP16XSD
• Device Lot Number: 2015601964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 10/23/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 10/30/2020; 02/11/2021
• Patient Sequence Number: 1