MAUDE Adverse Event Report: CARDINAL HEALTH 6206 A/R CHAMBER DRAIN BAG; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6206
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that two bags had tubes which arrived that were bent, so that the urine would not go through when in use.Additional information received on 19dec2023 stated that the two bags with the bent tubing were used, however, neither would allow the urine to pass through them.

• Brand Name: 6206 A/R CHAMBER DRAIN BAG
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18369638
• Report Number: 9612030-2023-03882
• Device Sequence Number: 7580403
• Product Code: KNX
• UDI-Device Identifier: 10884521001879
• UDI-Public: 10884521001879
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: 6206
• Device Catalogue Number: 6206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/20/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown