MAUDE Adverse Event Report: AESCULAP AG BOTTOM F/CONT.3/4 PERFORAT.HEIGHT:187MM; STERILIZATION CONTAINERS

Model Number JN744

Device Problem Residue After Decontamination (2325)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with jn744: bottom f/cont.3/4 perforat.Height: 187mm.According to the complaint description, residues were found on containers.Small rust colored and red dots or marks appear in the container.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the product arrived in a decontaminated condition with scratches and marks on the surface.Furthermore, the wall of the product is deformed, and we found deposits.The investigation was carried out visually and microscopically.We made a visual inspection of the products, here we detected some scratches and marks on the surface, a deformed wall, and deposits inside the product.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.According to the quality standard, a material defect and production error can most probably be excluded.Investigation leads to the assumption that the deposits was caused by reprocessing failure.Based upon the investigations results a product safety case(psc) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: BOTTOM F/CONT.3/4 PERFORAT.HEIGHT:187MM
• Type of Device: 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: 12488770
• MDR Text Key: 271929049
• Report Number: 9610612-2021-00608
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04046963449377
• UDI-Public: 4046963449377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JN744
• Device Catalogue Number: JN744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1