MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE; ACCESSORIES CONTAINER SYSTEM

Model Number JK100

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6).It was reported that the filter holder is detached.All med watch submissions related to this report are: 9610612-2017-00207, 9610612-2017-00208, 9610612-2017-00209, 9610612-2017-00210, 9610612-2017-00211.

Manufacturer Narrative

Investigation: the investigation was carried out visually.All seals are damaged or fallen off.All plates have the same maintenance date, october 2014 at ats in (b)(4).The silicone is brittle, as it is already several years old.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.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 an insufficient maintenance of the device.Rational: the maintenance of the retention plates has been carried out insufficiently.The silicon inlays are brittle due to normal aging.There is no maintenance instruction for retention plates available.Instead of using glue, the plates should have been replaced.Corrective action according to sop (b)(4) a capa is not necessary.

• Brand Name: FILTER RETENTION PLATE
• Type of Device: ACCESSORIES 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 ; 3145515988
• MDR Report Key: 6531449
• MDR Text Key: 74169045
• Report Number: 9610612-2017-00207
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K792558
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK100
• Device Catalogue Number: JK100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/17/2017
• Date Manufacturer Received: 02/21/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other