MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM PE LINER 48/28; DOUBLE MOBILITY PE LINER

Device Problems Device Contamination With Biological Material (2908); Device Packaging Compromised (2916)

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

Event Type  No Answer Provided  

Event Description

Ref imp# (b)(4).

Manufacturer Narrative

Batch review performed on 02 april 2015: lot 134971: (b)(4) liners manufactured and released on 12 december 2013.No anomalies found related to the issue reported.To date, (b)(4) liners of the lot have been sold without any similar problem.On 12 march the responsible of the packaging department performed the following action: the operator involved in this event has been identified and he was sensibilized on the seriousness of this event.On 12 mar 15 a training session was carried out to all the operators involved in the packaging process.The importance of specific procedures has been highlighted.

Manufacturer Narrative

On 07/03/2015, it was prepared a final report with the information collected during the investigation, already reported in the initial report and in the first follow up.On 07/07/2015, the report was sent to the initial reporter and the case was closed.

Manufacturer Narrative

Additional information: on 04/15/2015 the retrieved item have been analyzed by the packaging department responsible with the following outcomes: the presence of the hair is confirmed, positioned on the liner.The problem is probably due to a lack of attention of the operator who did not detect the hair.It is also possible that the headdress was not correctly positioned not preventing the fall of the hair.The operator was retrained.

• Brand Name: VERSAFITCUP DM PE LINER 48/28
• Type of Device: DOUBLE MOBILITY PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA INTERNATIONAL, SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: erin baumstark ; 3128782381
• MDR Report Key: 4660352
• MDR Text Key: 18071894
• Report Number: 3005180920-2015-00075
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1