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

Catalog Number	281113
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number of the tube set is unknown.
Event or Problem Description
When filling the pressure chamber fms vue 2 did not stop.Pressure increased until high pressure alarm was caused.Sales rep tested tube system with different fms pump and it worked fine.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.The complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point, no corrective action is required and no further action is warranted.However, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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 lot number is not currently available.Associated medwatch report number: 1221934-2018-50344.

• Brand Name: GRAVITY TUBE SET 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7366279
• Report Number: 1221934-2018-50348
• Device Sequence Number: 11340918
• Product Code: HRX
• UDI-Device Identifier: 10886705015856
• UDI-Public: 10886705015856
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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 Catalogue Number: 281113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/09/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1