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	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that after the balloon was inflated for testing, it did not deflate.
Additional Manufacturer Narrative
H6 investigation findings: 4247 - root cause undetermined.Investigation summary: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated device was received for evaluation.A visual and functional inspection was carried out per our procedure.The reported condition was observed; the catheter balloon presented difficulty when attempted to remove water with a syringe.The affected component is produced by an external supplier; our assembly process consists solely of a collection and placement operation of this material therefore the exact root cause was unable to be determined.The supplier was notified and awareness training for this type of issue will be conducted.There is no further action required at this time.This complaint will be used for tracking 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 sariava ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13446500
• Report Number: 9612030-2022-03157
• Device Sequence Number: 19913729
• 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
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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
• Device Lot Number: 2104826564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown