MAUDE Adverse Event Report: DEPUY MITEK LLC US INTERMEDIARY TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number	281103
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that the blue cap of the fms fluid management system intermediary tubing without one-way valve was off.During in-house engineering evaluation, it was determined that the ¿female vented cap blue¿ was detached from the tip on the device.There was no procedure nor patient involvement reported.No additional information was provided.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.The package was unopened.It was observed that the ¿female vented cap blue¿ was detached from the tip.The external packaging did not present any anomalies.A manufacturing record evaluation was performed for the finished device number: 3001981 , and no non-conformances were identified.Based on the condition of the device received, this complaint can be confirmed.A manufacturing investigation will be performed; the process was reviewed, and it was found that the work instructions for part numbers 284610, 281103, where the blue vented cap (p3101312) is used, does not instruct the operator to screw in the cap to the blue male luer-lock p3101369.Although instructions are vague, it is generally understood by operators that the cap must be screwed onto the luer, and therefore only one loose cap was discovered for lot 3001981.The corrective actions are a quality alert was posted on the production floor and training was performed with operators.Ppcr 22-0279 was generated to update work instructions for part numbers 284610 and 281103 to instruct operators to screw the blue cap (p3101312) onto the blue male luer lock (p3101369).As agreed, a nonconformance record was created to document the root cause and identify a corrective and/or preventive action plan.The manufacturer will continue to manufacture the product under the rigorous requirements of our certified quality management system.At this point in time, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: INTERMEDIARY TUBESET 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14547549
• Report Number: 1221934-2022-01523
• Device Sequence Number: 4957072
• Product Code: HRX
• UDI-Device Identifier: 10886705015764
• UDI-Public: 10886705015764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: 281103
• Device Catalogue Number: 281103
• Device Lot Number: 3001981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown