MAUDE Adverse Event Report: AESCULAP AG PRIMELINE 3/4 LID ANTHRACITE; STERILIZATION CONTAINERS

Model Number	JP016
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with jp016 - primeline 3/4 lid anthracite.According to the complaint description, the lid disconnected.One lid cracked in the middle, and another lid popped off the container during sterilization.There was a significant surgery delay of 40 minutes.Staff had been setting up and preparing for a vitrectomy procedure.There was no patient involvement.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00645 (400528225 - jp016).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: PRIMELINE 3/4 LID ANTHRACITE
• Common Device Name: STERILIZATION CONTAINERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12577672
• Report Number: 9610612-2021-00644
• Device Sequence Number: 3787996
• Product Code: KCT
• UDI-Device Identifier: 04038653354788
• UDI-Public: 4038653354788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: JP016
• Device Catalogue Number: JP016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown