MAUDE Adverse Event Report: CARDINAL HEALTH URINARY LEG BAG,MED.; BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Model Number	145514
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 creases in the anti-reflux valve prevented the urine from flowing through.No injury was caused to the patient.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality requirements.The sample did not return because it was discarded.The reported condition was unable to be confirmed.The root cause could not be determined.No action is required.Functional inspection and testing are performed on the finished product to check functionality (occlusion/leak) before releasing.This complaint will be used for tracking and trending purposes.

• Brand Name: URINARY LEG BAG,MED.
• Common Device Name: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
• Manufacturer (Section D): CARDINAL HEALTH; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• Manufacturer (Section G): CARDINAL HEALTH; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13333320
• Report Number: 8040459-2022-00570
• Device Sequence Number: 17421391
• Product Code: FAQ
• UDI-Device Identifier: 20884521009766
• UDI-Public: 20884521009766
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 145514
• Device Catalogue Number: 145514
• Device Lot Number: 2119444FUB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/09/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown