MAUDE Adverse Event Report: AESCULAP AG SINGLE USE PAPER FILTER WITH INDICATOR; DISPOSABLES CONTAINER SYSTEM

Model Number JK095

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/31/2021

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 jk095 - single use paper filter with indicator according to the complaint description, the 3 boxes having been autoclaved on two different days in sterilization have paper filters that do not conform.There are micro holes on all the filters.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4) associated medwatch-reports: 9610612-2021-00462 (400516336 - jk095).

Manufacturer Narrative

Additional information - d4 (udi).Investigation results visual investigation the product received us in an decontaminated condition.There was no deviation or micro holes could be detected.Furthermore the products were sent to the manufacturer for further analysis.Based on the analysis there are no holes could be detected as well.The marked areas are thin spots which cannot be avoided during the production of the raw material.Additionally the external laboratory confirms that germ-tightness is ensured at the thin spots.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: there is no indication for a material-, manufacturing- or design-related failure.There was no product deviation founded.Based upon the investigations results a capa is not necessary.

Manufacturer Narrative

Additional information: based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.No failure was detected during investigation the device function as intended.

• Brand Name: SINGLE USE PAPER FILTER WITH INDICATOR
• Type of Device: DISPOSABLES CONTAINER SYSTEM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12042907
• MDR Text Key: 265655833
• Report Number: 9610612-2021-00458
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

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
• Device Operator: Health Professional
• Device Model Number: JK095
• Device Catalogue Number: JK095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 08/10/2021
• Supplement Dates FDA Received: 08/12/2021; 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1