MAUDE Adverse Event Report: COVIDIEN CURITY ANTI-REF 18FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	8948MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
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 approximately 7 cc of water was drawn out via syringe but no additional water could be drawn out of the catheter balloon at the time of removal.The physician slowly pulled out the catheter and the balloon remained slightly inflated.No patient injury/harm was reported.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported approximately 7cc of water was drawn out via syringe but no additional water could be drawn out at the time of removal.The physician slowly pulled out the catheter and the balloon remained slightly inflated.No patient injury/harm was reported.A device history record (dhr) review was unable to be performed as the lot number reported was unknown.Failure mode trending was reviewed and no related trends were identified.One (1) decontaminated drainage bag with date code 268-9n6 was received for evaluation.Visual inspection and functional evaluation performed were unable to confirm the reported device issue.The returned device met specification and functioned as anticipated.Additional action will not be taken at this time.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: CURITY ANTI-REF 18FR 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: 11731451
• Report Number: 9612030-2021-02879
• Device Sequence Number: 17166866
• Product Code: KNX
• UDI-Device Identifier: 10884521050662
• UDI-Public: 10884521050662
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: Health Professional
• Device Model Number: 8948MF
• Device Catalogue Number: 8948MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1