MAUDE Adverse Event Report: CARDINAL HEALTH 1616G LTX CATH 5 CC 2-WAY 16FR; CATHETER, UROLOGICAL

Model Number	1616
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a pinhole was found during the balloon test prior to use.There was no patient use.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section d4: lot number and unique identifier (udi)# updated.Section h4: device manufacture date updated.The device was received for evaluation.The lot number was provided along with the returned device.The device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The product was manufactured on 3rd august 2023.The balloon was inflated with 10ml as per requirement and a balloon leak was confirmed.A pinhole was found at the balloon edge area.This pinhole was caused by the bubbles trapped in the latex and when dipping this bubble attached to the catheter, thus, causing the bubble area was not covered with latex throughout the dipping process.100% inspection for balloon was performed for all catheters, however this 100% inspection used air inflation method instead of water inflation method.The pressure exerted by air was different than water.Thus, this condition could not be detected during 100% inspection.A non-conformance (nc) was issued to address bubbles trapped in latex.This nc was closed in 2023.The affected batch was manufactured before the implementation of this nc.Thus, the action taken was considered effective.

• Brand Name: 1616G LTX CATH 5 CC 2-WAY 16FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19819213
• Report Number: 1423537-2024-00083
• Device Sequence Number: 8781008
• Product Code: KOD
• UDI-Device Identifier: 10192253026146
• UDI-Public: (01)10192253026146(17)281030(10)3304U12QX
• 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): 09/03/2024

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: 1616
• Device Catalogue Number: 1616
• Device Lot Number: 3304U12QX
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown