MAUDE Adverse Event Report: CARDINAL HEALTH CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
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 the tube of the urinary drainage bag was kinking and it wouldn't let urine flow through.There was no patient harm.
Additional Manufacturer Narrative
Investigation conclusion the customer reported when the package was opened, it was found that the tube of the urinary drainage bag was kinking and won't let urine flow through.There was no patient harm.The device history record review could not be performed since no lot number was provided from customer complaint report, and no photo sample/actual sample with lot number was received.One decontaminated sample without a lot number was received for evaluation.The analysis of the sample was carried out and a kink was identified on the pvc tube.A review was performed through the manufacturing process, all processes and controls were found to be adequately followed, including sub-assemblies, finished product assembly, and product packaging and inspections.In addition, product quality control inspections were carried out for material release; and a 100% visual inspection is carried out by the production personnel during the packaging process.Since assembly process for coiling is a manually process performed by the operator, is possible that coiling process was not performed according to the assembly method.The actions implemented in the assembly process, as a containment action, a quality alert was generated as an additional measure for the correct storage and coiling of the material in the assembly process; in addition, personnel production received an awareness notification from the condition reported.This complaint will be used for monitoring and trending purposes.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12865390
• Report Number: 9612030-2021-03099
• Device Sequence Number: 4364582
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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
• Device Model Number: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown