MAUDE Adverse Event Report: AESCULAP AG MINI-SIZE LID W/RETENTION PLATESILVER MINI CONTAINER BOTTOMS AND LIDS

Model Number JK174

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6). It is reported that the seals are faulty. Components in use listed as concomitant devices are: jk174 / mini-size lid w/retention platesilver. Jk188 / bottom f/mini container height: 57 mm.

• Brand Name: MINI-SIZE LID W/RETENTION PLATESILVER
• Type of Device: MINI CONTAINER BOTTOMS AND LIDS
• 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: 7334583
• Report Number: 9610612-2018-00113
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: JK174
• Device Catalogue Number: JK174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 03/12/2018
• Event Location: No Information
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other