MAUDE Adverse Event Report: CARDINAL HEALTH CATH FOLEY SIL ELSTMR 5CC 16FR; CATHETER, UROLOGICAL

Model Number	402716
Medical Device Problem Code	Material Rupture (1546)
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
Customer reports: there was an a hole in the urinary tube balloon therefore it was not possible to inflate the balloon.Per additional information received on 11/21/23, the hole was at the level of the balloon.
Additional Manufacturer Narrative
A product sample was received for evaluation.The sample received was physically inspected.The balloon was inflated with 10ml as per requirement and a balloon leak was confirmed.The catheter was inspected under dinolite camera, and a pinhole was found at the balloon edge area.This pinhole was caused by the weak balloon edge due to the low sdt value for reinforcement latex layer.100% inspection for balloon was performed for all catheters, however this 100% inspection used air inflation method not water inflation method.The pressure exerted by air was different than water.Thus, this defect could not be detected during 100% inspection.This lot was manufactured as per defined device master record.All acceptance criteria met, and this lot was released meeting all the acceptance criteria.The pinhole was caused by a weak balloon edge.This weak balloon edge was due to the low sdt value of reinforcement latex.No corrective/preventative actions (capa) will be escalated since the reported issue falls under a risk that was not a new hazard identified and reduced occurrence for latex urinary catheters.A quality alert will be issued for this type of complaint and to emphasize the importance to monitor the sdt value for the latex.Section e1: the initial reporter address has been updated.

• Brand Name: CATH FOLEY SIL ELSTMR 5CC 16FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA
• Manufacturer (Section G): CARDINAL HEALTH; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18185773
• Report Number: 9611712-2023-00142
• Device Sequence Number: 12566639
• Product Code: KOD
• UDI-Device Identifier: 10884521016163
• UDI-Public: 10884521016163
• 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): 02/14/2024

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: 402716
• Device Catalogue Number: 402716
• Device Lot Number: 3126S12QX
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/14/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown