MAUDE Adverse Event Report: CARDINAL HEALTH 6308 2000ML DRAIN BG W SPOUT; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6308
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
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 clogging occurred at the round part where the tube and bag are connected.There was no patient harm.The duration of use is unknown.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used sample without its original packaging was received for the evaluation.A visual inspection of the received sample was performed, in additional a functional test was carried out.The bag was filled to its maximum capacity (2000 ml).The investigation was carried out with the multifunctional team.Upon evaluation, the reported problem could not be confirmed.The bag was filled to its maximum capacity without observing any condition that prevented its filling.All processes were reviewed.All processes and controls were found to be properly followed, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 6308 2000ML DRAIN BG W SPOUT
• 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: 13348775
• Report Number: 9612030-2022-03143
• Device Sequence Number: 4984223
• Product Code: KNX
• UDI-Device Identifier: 10884521002050
• UDI-Public: 10884521002050
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 6308
• Device Catalogue Number: 6308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown