MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 2500CC CANISTER, 2 ELBOW; 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	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the true root cause could not be determined due to inability to evaluate the affected sample as well as the inability to reproduce the failure mode.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (call number (b)(4) was received reporting a crack in a suction canister (part number v71-1107).The end user reported hearing popping noises during use.The affected sample could not be returned due to contamination.A sample picture was provided and confirmed a crack at the bottom of the canister.As a part of the investigation, a canister was intentionally cracked and shutoff testing performed using this canister.The unit pulled fluid and contained it.Audible sounds were heard, but these sounds did not resemble popping sounds.Because no popping noises were exhibited, it is believed the canister was not cracked prior to use.Two molds manufacture the reported item number.Due to no sample or reported lot number, it is unknown which mold manufactured the affected part.Therefore, samples from both molds were functionally tested.A shut off test was performed followed by an extended vacuum test.All samples passed.Additionally, a visual inspection was performed on each sample for any abnormalities that could have contributed to the reported failure mode.No abnormalities were observed.There has been no change to the raw material or to the machine that manufactures this product.From 2019 to year-to-date 2020, there has been no internal occurrences of this part number failing an in-process test.In the past 2 years, 45,170 cases of this item number have been sold.During the same time period, one complaint was filed, yielding a complaint-to-sales ratio of 0.00221 percent.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
There is a crack at the bottom of the suction can.The staff have been hearing popping noises during procedures.

• Brand Name: 2500CC CANISTER, 2 ELBOW
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• MDR Report Key: 10217813
• Report Number: 1057404-2020-00002
• Device Sequence Number: 2552392
• 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): 06/30/2020

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: 06/01/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1