MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE INJECTOR II NEEDLE CARTRIDGE; NEEDLE, SUTURING, DISPOSABLE

Model Number	CAT01857
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was foreign material inside the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: injector packaging had a few small pieces of blue or black plastic.It was reported to me by the scrub tech and circulating nurse while they were opening.To be more specific, the small plastic pieces were in the packaging floating around.Thanks! the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) severe shipping conditions or 2) manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was foreign material inside the sterile packaging.

• Brand Name: INJECTOR II NEEDLE CARTRIDGE
• Common Device Name: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11761576
• Report Number: 0002936485-2021-00237
• Device Sequence Number: 19956252
• Product Code: GAB
• UDI-Device Identifier: 07613252633105
• UDI-Public: 07613252633105
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/18/2021

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 Model Number: CAT01857
• Device Catalogue Number: CAT01857
• Device Lot Number: 005903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1