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

Model Number	V71-1107
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During a procedure, a crack was observed at the bottom of a suction can.

• Brand Name: 2500CC CANISTER
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• MDR Report Key: 10431549
• Report Number: 1057404-2020-00004
• Device Sequence Number: 2392371
• Product Code: KDQ
• UDI-Device Identifier: 00749756603928
• UDI-Public: 00749756603928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V71-1107
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1