MAUDE Adverse Event Report: CARDINAL HEALTH CATH ROBINSON URETH 10 FR; CATHETER, UROLOGICAL

Model Number	400610
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer says there are several catheters that were not open at the tip, therefore unusable.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
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 condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Five photographic samples and 7 decontaminated samples were submitted for evaluation.The photos confirmed that the catheter eyelets were missing.The decontaminated samples did not have the perforation of the eyelets in the catheters; the reported condition was confirmed.A walk through of the manufacturing process was conducted and found that current process and controls were followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No conditions were found that could trigger the reported condition.The root cause would be that since the assembly process consists of manually placing the component in the machine cavity, it is possible that the operation has not been followed correctly.An awareness notification was issued to production personnel to heighten awareness of the reported condition with a quality alert.A change was made to the visual inspection level from reduced to a more rigorous inspection for the subassembly of this product.

• Brand Name: CATH ROBINSON URETH 10 FR
• Common Device Name: CATHETER, UROLOGICAL
• 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 saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16930888
• Report Number: 9612030-2023-03697
• Device Sequence Number: 20513236
• Product Code: KOD
• UDI-Device Identifier: 10884521008823
• UDI-Public: 10884521008823
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/11/2023

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: 400610
• Device Catalogue Number: 400610
• Device Lot Number: 2017512164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown