MAUDE Adverse Event Report: CARDINAL HEALTH JACKSONVILLE LINER CANNSTR SUCT 3000CC DISP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-530

Device Problem Burst Container or Vessel (1074)

Patient Problem Hearing Loss (1882)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.No sample was provided by the customer; therefore, 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.Based on the information provided, no specific cause can be determined.If the lid had a crack before applying suction, this would prevent the unit from functioning as intended and could cause the unit to implode.Packaged canisters or lids, when they are opened at the customer site, may exhibit the cracked unit although no apparent damage is evident on the outside of the box itself.If the unit was damaged prior to shipping, this unit was not included in any inspection sampling or noted during other processing steps.Although not verifiable, the 'at customer site' unit may have received previous damage during processing, pack-out, or subsequent shipping and handling including at the customer site prior to use.A damaged or cracked lid would not meet the requirements of the vacuum stress associated with the use of the product.Without a specific assignable cause, no specific corrective action can be taken; however, we will continue to monitor concerns such as these for possible future actions.For customer awareness, it is recommended that the customer review the unit for damage prior to use and replace cracked or damaged units prior to use.Per the directions for use included with the product, it is not recommended to subject the canister to vacuum when not in use.Trending of past product quality reports indicate that this is the 5th reported incident for an implosion event for the 65651-530 product code in the past 3 calendar years.The (b)(4) 65651-530 units have been sold during the past three calendar years.

Event Description

Customer has reported that the lid of the liner blew up (imploded).She stated the red lid went into a million little pieces and contaminated sterile field.Customer also stated that the dr.Has hearing loss, not positive if directly related to this specific incident as she has not had time to investigate.Pieces of lid are available, but hospital will not released at this time until they complete their investigation.

• Brand Name: LINER CANNSTR SUCT 3000CC DISP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7142170
• MDR Text Key: 95937242
• Report Number: 1423537-2017-00145
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140152729
• UDI-Public: 00630140152729
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 65651-530
• Device Catalogue Number: 65651-530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention