MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 2500CC CANISTER; BOTTLE, COLLECTION, VACUUM

Model Number V71-1107

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: the root cause could not be determined due to the following reasons: no sample returned for evaluation; only one item number out of three using the same mold and material is exhibiting the reported issue; inability to determine if the account is using a chemical on the product for purposes such as cleaning; and inability to reproduce the reported issue internally without use of chemicals.Corrective action: a corrective action has not been taken due to inability to determine root cause.Investigation summary: an internal complaint (b)(4) was received indicating a 2500 cc canister (part number v71-1107) cracked during use.The defective device was not returned.A photograph of the defective device was provided and confirmed the reported issue.This is the fourth report of this type in 2020.(b)(4).Of the four reports received in 2020, three of these have been from the same customer.All reports have been for the same item number.There are three part numbers (71-1103, 71-1107, and v71-1107) manufactured using the same mold.Reports of cracking have only occurred with part number v71-1107.Additionally, similar reports have not occurred for the other canister sizes.The fact that the reports are isolated to one part number would seem to eliminate the possibility of a mold or material issue.Canisters from two molds were evaluated.This evaluation included placing the canisters under extended vacuum and testing resistance to implosion.All samples tested met specifications, and the issue could not be reproduced.Inspections of recent manufactured lots were evaluated, and all product met specification.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

During a procedure, a crack was observed at the bottom of a suction can.

• Brand Name: 2500CC CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 10431549
• MDR Text Key: 204221425
• Report Number: 1057404-2020-00004
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00749756603928
• UDI-Public: 00749756603928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V71-1107
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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