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	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
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 the balloon was unable to be removed.A needle was inserted into the balloon lumen and it was able to be removed.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added.H3: evaluation summary: the device history record (dhr) was reviewed using the immersion lot number from the catheter, this product was manufactured according to the established device master record.No deviation was noted on all processing material and parameters.All quality control inspection criteria had been fulfilled.The sample was examined by the supplier of the product.It was examined under a magnifying camera for physical inspection.A clamping mark was found on the shaft.This clamping mark caused the balloon airline to constrict and collapse.The most likely root cause of the reported issue is too much pressure was put on the catheter by clamping for a prolong period.This can cause the airline to be dented and collapsed.The collapsed airline causes partial deflation and makes the balloon unable to be deflated as it should.This complaint was not a result of the manufacturing process.As the reported condition was not induced by the manufacturing process, corrective action will be limited to manufacturing site awareness.Awareness training will be provided to the operator of the manufacturing machines.No further corrective action is required at this time.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): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10747827
• Report Number: 9612030-2020-02680
• Device Sequence Number: 1767909
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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
• Operator of Device: No Information
• Device Model Number: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1