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

Model Number JK095

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Pierced filter.The hole was found during the control of the filters in the room, it is located at the extremity of the disc.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the filter.Here we found a hole in the filter.Additionally we found unknown impurities.Batch history review: the device quality and manufacturing history records have been checked for both lot numbers and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.No capa is necessary.

• 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 ; 3145515988
• MDR Report Key: 7169976
• MDR Text Key: 96592254
• Report Number: 9610612-2018-00012
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/13/2018

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: 01/05/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/05/2018
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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