MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD MEDI-VAC ® FLEX ADVANTAGE® - 1500 ML; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651920

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.A review of the manufacturing device history record for lot number 17g03 provided by the customer was completed.The product was manufactured (b)(6) 2017.No non-conformance with regard to ¿cracked lids¿ or ¿imploded lids¿ were documented during the manufacturing of this batch.This investigation determined that all products were manufactured, inspected, and released in accordance to our established specifications for quality and efficacy.No sample was provided by the customer thus an evaluation of the complaint device for deficiency of construction could not be performed.Note: if the event sample is received at a later date and provides a different conclusion, an addendum report will be written.Without the actual event sample involved in the customer incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.Trending of past product quality reports indicate that this is the 1st reported incident regarding imploded flex lid in the past calendar year for this particular part number.No further action is planned at this time.

Event Description

Liner used for lipoaspiration with usual pressure at -600mmhg: the liner imploded and the lid was violently sucked at the bottom of the liner.This caused an important noise and splash of biological liquids collected.No clinical consequence for the patient.

• Brand Name: MEDI-VAC ® FLEX ADVANTAGE® - 1500 ML
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer (Section G): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7183474
• MDR Text Key: 97742577
• Report Number: 1423537-2018-00148
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 65651920
• Device Catalogue Number: 65651920
• Device Lot Number: 17G03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention