MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET

Catalog Number	0210100000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the tubing in the package looks discolored found out of the box.There was no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Based on the original reported event, the event was assessed as likely to cause or contribute to a serious injury or require medical intervention to prevent a serious injury if it should recur.After completing our device evaluation and obtaining additional information, it was determined that this event did not involve bio-contamination and is not likely to cause or contribute to a serious injury or require medical intervention to prevent a serious injury and is therefore not reportable.
Event or Problem Description
The user facility reported that the tubing in the package looks discolored found out of the box.There was no delay, no medical intervention, and no adverse consequences.

• Brand Name: INTERPULSE HANDPIECE SET WITH SUCTION TUBING
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 8466447
• Report Number: 0001811755-2019-01024
• Device Sequence Number: 345226
• Product Code: FQH
• UDI-Device Identifier: 34546540144219
• UDI-Public: 34546540144219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 0210100000
• Device Lot Number: 17243032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1