MAUDE Adverse Event Report: COVIDIEN FRANCE PRC ADV 12FR L UL F TY; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER

Model Number	FPP12UL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
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 that the indwelling catheter was defective, despite checking the balloon (non-porous) and leakage, there was poor emptying.The probe was removed, and a new functional ch14 indwelling probe was inserted.Additional information received from the customer stated that there was a poor urine drainage.The patient experienced acute urine retention and hyperalgesia, as the result of the product malfunction.The customer had contacted the nurse and the nurse explained that, she did a test on the balloon, which did not show any porosity.The catheter was also tested without any obstacles.The urine was clear.There were no specific problems with the tests, but due to the increase in vesicular globe and urine retention with strong pain, it was decided to replace the catheter with a new catheter with a larger hinge and the problem was resolved.It was unknown if any treatment was provided for the acute urinary retention issue and hyperalgesia.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that the indwelling catheter was defective, despite checking the balloon (non-porous) and leakage, there was poor emptying.The probe was removed, and a new functional ch14 indwelling probe was inserted.Additional information received from the customer stated that there was a poor urine drainage.The patient experienced acute urine retention and hyperalgesia, as the result of the product malfunction.The customer had contacted the nurse and the nurse explained that, she did a test on the balloon, which did not show any porosity.The catheter was also tested without any obstacles.The urine was clear.There were no specific problems with the tests, but due to the increase in vesicular globe and urine retention with strong pain, it was decided to replace the catheter with a new catheter with a larger hinge and the problem was resolved.It was unknown if any treatment was provided for the acute urinary retention issue and hyperalgesia.Additional information was provided by the customer and it was stated that paracetamol was given in order to decrease the induced pain.

• Brand Name: FRANCE PRC ADV 12FR L UL F TY
• Common Device Name: URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10614209
• Report Number: 9612030-2020-02634
• Device Sequence Number: 18941894
• Product Code: FCN
• UDI-Device Identifier: 10884521046702
• UDI-Public: 10884521046702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: FPP12UL
• Device Catalogue Number: FPP12UL
• Device Lot Number: 1833815864
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other