MAUDE Adverse Event Report: COVIDIEN DOVER SLVR FOLEY CATH16FR5CC2W; CATHETER, RETENTION TYPE, BALLOON

Model Number	605163IC
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	03/23/2021
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 that the catheter broke apart where the two-way prong connects to the tube.There was no patient injury, the issue occurred before the nurse inserted the catheter.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot indicates that there were no anomalies found in visual samples inspected from the lot and no non-conformance reports issued for this lot.Prior to a lot¿s release, the lot must be deemed acceptable, passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for leakage in the fluid pathway.The lot met all defined acceptance requirements and was released.One decontaminated dover catheter was received for evaluation.The sample was visually inspected according to procedure; the reported condition was confirmed.The component is produced by external supplier and the assembly process consists of a pick and place operation at the cardinal health facility.The root cause for the condition was requested from the manufacturer and will be documented through the supplier notification and response form.There is no additional inspection on the line to detect the reported condition.We are awaiting an action plan to be implement by the supplier for the corrective actions.The cardinal health facility will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOVER SLVR FOLEY CATH16FR5CC2W
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11599875
• Report Number: 9612030-2021-02834
• Device Sequence Number: 14326489
• Product Code: EZL
• UDI-Device Identifier: 10884521026452
• UDI-Public: 10884521026452
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 605163IC
• Device Catalogue Number: 605163IC
• Device Lot Number: 1934434064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1