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

Model Number JK095

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).Foreign particle looked hair was found in the package.

Manufacturer Narrative

Investigation: the investigation was carried out visually.Without opening the plastic bag, a hair can be found.Furthermore the filters were forwarded to the manufacturer for investigation.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to a manufacturing error.Rational: according to the statement from the r&d department, hairs or other foreign particles are not allowed in the packing.The manufacturer will implement several improvement activities: the process of changing garments, correct wearing of the hairnet, defined areas.A capa will be carried out by the manufacturer.

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7322064
• MDR Text Key: 101983656
• Report Number: 9610612-2018-00066
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: JK095
• Device Catalogue Number: JK095
• Device Lot Number: 4508838749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2018
• Device Age: 9 MO
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other