MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SAFELINER SUCTION CANISTER, 3000CC; BOTTLE, COLLECTION, VACUUM

Catalog Number 71-6530

Device Problems Fluid/Blood Leak (1250); Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that finished good (b)(4) overflowed and allowed fluid to leak into the hospital's system.The lot number was not reported, and defective sample was not returned for evaluation.Without the sample, visual evaluations and testing are not able to completed.Because a lot number was not reported, the device history record (dhr) was reviewed for discrepancies for lot numbers shipped to the account since december.Lot numbers identified with ship dates included in parentheses are as follows: 40937480 (12/2/2015), 41169890 (12/28/15), and 41195174 (1/11/16).Lot number 41348231 (1/29/2016) was excluded from that list due the date occurrence.No discrepancies were found in the dhr review.The failure mode effects and criticality analysis (fmea) was reviewed.The failure mode reported was identified with the following provided as potential causes: 1) manufacturing error; 2) damaged device; and 3) user error.The quality control complaint specialist reviewed the sales and similar complaint information.(b)(4).There have been no previous reports during the review period for the finished good and issue reported.Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue.The investigation is incomplete at this time.If new and critical information is received, this report will be updated.Device not returned to manufacturer.

Event Description

The product was connected to the vacuum system when it overflowed and liquid leaked into the system.The product was being used for its intended purpose of spill-safe waste fluid management.Since the waste fluid leaked into the system, the hospital will have to have the entire system professionally cleaned out to prevent further infectious contamination.

• Brand Name: SAFELINER SUCTION CANISTER, 3000CC
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 5463053
• MDR Text Key: 39118798
• Report Number: 2320762-2016-00001
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71-6530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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