MAUDE Adverse Event Report: COVIDIEN 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	06/21/2021
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
The customer reported an accidental balloon removal occurred and they noticed the balloon had ruptured into fragments.The drugs used were benzalkonium chloride solution and what was packed in the package only.Duration of use was about 2 days.There was no patient harm.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported an accidental balloon removal.The drugs used were benzalkonium chloride solution and what was packed in the package only.Duration of use states to be about two (2) days.A device history record review could not be performed because a lot number reported was unknown.Failure mode trending via history complaint review did not identify any related adverse trending.One (1) decontaminated sample was returned for evaluation with lot number 14319075.In addition, five (5) photographs were provided for evaluation.Visual inspection of the photographs confirmed the reported defect.Visual inspection of the returned device confirmed specification was not met as the balloon was confirmed to have ruptured.The affected device component is produced by an external supplier and an supplier investigation request has been initiated/submitted.At this time, no further action will be taken.We will continue to monitor and trend the confirmed product issue.
Additional Manufacturer Narrative
Supplier investigation results were provided as follows: a burst balloon for a latex foley catheter can be caused by a weak balloon, petroleum lubricant used during insertion, chemical reaction in the urine or to or application of chemicals during insertion.The pattern of the burst balloon observed under dinolite indicated the burst balloon to be caused by the usage of petroleum lubricant or a chemical reaction.It was mentioned that customer applied benzalkonium chloride solution and others which was packed together with the affected catheter.If benzalkonium chloride solution which was used as sanitizing agent and also contained petroleum, this will cause the balloon to burst.Foley catheter are sensitive to any petroleum based chemicals and will caused burst balloon.Thus, user should not apply any petroleum based chemicals while using this catheter.Corrective actions taken to eliminate the cause of a detected nonconformity and to prevent recurrence are to ensure the scope of the manufacturing process maintains product specification and validation.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; 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: 12123759
• Report Number: 9612030-2021-02971
• Device Sequence Number: 11864934
• 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): 11/05/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 06/22/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/24/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown