MAUDE Adverse Event Report: CARDINAL HEALTH 2565 REPLOGLE CATH 10 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256503
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the item was defective and malfunctioning.Per additional information received on from the customer on (b)(6), 2022, there were no number markings on the tube.The nurse caring for the patient noticed as she was preparing the exchange, that she was unable to measure the depth appropriately.There was no medical intervention required as the product did not reach the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record file was reviewed, and no discrepancy was found according to the condition reported.One sample with lot number 2201144164 was received for evaluation.After performing a visual inspection, missing depth marks were observed.The analysis performed by the multi-functional reveals that this condition is a workmanship issue; missing marks is a condition generated when an operator fails to complete an impression or follow the predetermined process steps to assure a complete impression.This incident is considered an isolated event.However, a quality alert was issued to notify the production personnel for awareness.No further actions are needed at this time.This compliant will be used for tracking and trending purposes.

• Brand Name: 2565 REPLOGLE CATH 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• 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: 15432718
• Report Number: 9612030-2022-03391
• Device Sequence Number: 12267192
• Product Code: BSY
• UDI-Device Identifier: 10884527006427
• UDI-Public: 10884527006427
• 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): 11/18/2022

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: 8888256503
• Device Catalogue Number: 8888256503
• Device Lot Number: 2201144164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown