MAUDE Adverse Event Report: AESCULAP INC MINI-SZ FILTER W/O INDICATOR; DISPOSABLES

Model Number US999

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing 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 the mini-size filters.After the instrument sets reached the operating room, holes were noted in the filters.The trays were for implants and not instruments.The malfunction did not cause patient harm; there was an unspecified delay in surgery.Additional information was not provided.

Manufacturer Narrative

Updated sections: d1, d4- model #, catalog #, udi #.Manufacturing site evaluation: manufacturer received no samples, samples would have been supportive to determine the physical shape & size & frequency of the punctured areas in order to try to identify in our converting process a potential step which have generated such defects.Given the manufacturing batch record and product retains could not be reviewed, nor were there photos or returned product provided, manufacturer was unable to perform a targeted investigation.As such, no additional corrective action will be taken at this time other than to continue to monitor the complaint database for any reoccurrence.

Manufacturer Narrative

Additional information: based upon new information, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: MINI-SZ FILTER W/O INDICATOR
• Type of Device: DISPOSABLES
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8957167
• MDR Text Key: 158628214
• Report Number: 2916714-2019-00055
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US999
• Device Catalogue Number: US999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSTRUMENT SET