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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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.
Event or Problem Description
The customer reported that during use, the catheter was detached from the urinary drainage bag.There was no patient harm reported.
Additional Manufacturer Narrative
One decontaminated drainage bag with date code 203-0d61 was received for evaluation.According to the date code 203-0d61 printed on the bag, the product belongs to the code 6162mf and the batches manufactured according to the date code are 2019605864 and 2019800564.A visual inspection was carried out according to our procedure; the pvc tube was detached from the drip chamber of the bag.The issue reported was confirmed.The device history record (dhr) was reviewed for both possible lot numbers, and no abnormal process conditions were present during the manufacturing of the products that could have led to the condition in this complaint.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The issue was investigated by the cross-functional team.All processes and controls were found to be adequately followed, including sub-assemblies, finished product assembly, and product packaging and inspections.According to the results of the investigation carried out, the exact root cause could not be determined.The failure was evaluated against the acceptable quality limit (aql).No action plan is necessary as the complaint reported represents a failure rate much below the approved aql and no adverse trend exists at this time.A notification was provided to all production personnel to make them aware of this incident.We will keep monitoring the process for any adverse trends that require immediate attention.

• 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: 12410709
• Report Number: 9612030-2021-03036
• Device Sequence Number: 3549549
• 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): 10/28/2021

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: 09/01/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1