MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK); HOLOGRAPH, FETAL, ACOUSTICAL

Catalog Number	0620040660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was foreign material inside of the sterile packaging.
Event or Problem Description
It was reported that there was foreign material inside of the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: hair inside sealed packaging.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be extreme shipping conditions or storage conditions the product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

• Brand Name: PKG; HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)
• Common Device Name: HOLOGRAPH, FETAL, ACOUSTICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7617340
• Report Number: 0002936485-2018-00491
• Device Sequence Number: 1383827
• Product Code: HIF
• UDI-Device Identifier: 37613327055628
• UDI-Public: 37613327055628
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: Other
• Device Catalogue Number: 0620040660
• Device Lot Number: 56005972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1