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

Catalog Number 284504

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep. In colombia that their artrosc pump irrigation hose had water leak issue during an unspecified surgery. The sales rep. Stated that the validation was carried out and it was evidenced that the device was broken. It was not reported if there was a delay in the surgical procedure or if a spare device was available for use. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: IRRIGATION TUBESET 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8201033
• MDR Text Key: 131605383
• Report Number: 1221934-2018-55856
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 284504
• Device Lot Number: 2995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial