MAUDE Adverse Event Report: CARDINAL HEALTH CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.¿ if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.¿ as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: indwelling balloon burst.No patient harm.The duration of use is unknown.Additional information was provided upon the verification performed at covidien (b)(4), the balloon did burst with fragments.
Additional Manufacturer Narrative
Evaluation summary: 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 reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The sample was received at the manufacturing site for evaluation.The sample was observed under the camera, and the burst balloon was confirmed.Based on the pattern of the burst balloon observed, this burst was not caused by a manufacturing issue.The pattern of the burst balloon shows it was caused by the usage of petroleum lubricant.Foley catheters manufactured from this site are sensitive to any petroleum-based chemicals and petroleum will cause a burst balloon.Thus, the user should not apply any petroleum-based chemicals while using this catheter.This product was manufactured according to the established device master record.No deviation noted on all processing material and parameters.All quality control inspection criteria had been fulfilled satisfactorily.This issue was not a manufacturing related condition.This complaint will be used for tracking and trending purposes.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• 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: 12618591
• Report Number: 9612030-2021-03058
• Device Sequence Number: 3473822
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• 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,Followup
• Report Date (Section B): 03/08/2022

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: 6162MF
• Device Catalogue Number: 6162MF
• Device Lot Number: 2029404664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021; 09/24/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/16/2021; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown