MAUDE Adverse Event Report: PLEURX DRAINAGE KIT 500ML; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7205B
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 2326010 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported via email: the sales rep's personal item connection was burred at tip.Per rep: pleurx vacuum bottle connection flaw.Photo provided shows flash at access tip.
Event or Problem Description
It was reported via email: the sales rep's personal item connection was burred at tip.Per rep: pleurx vacuum bottle connection flaw.Photo provided shows flash at access tip.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: one photo was provided to our quality team for investigation.Through visual inspection, excess pieces of plastic are observed on the end of the access tip, verifying the reported failure.A review of the internal manufacturing device records and raw material history files for reported lot 0001352657 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.General wear on the manufacturing equipment can contribute to this defect.Product undergoes inspections throughout manufacturing, any product identified during these inspections undergoes a process to remove the excess pieces on the access tip.It was determined this failure is due to the machine as well as personnel not following procedure to properly removed the excess pieces at the access tip.A corrective action project was opened to further investigate and address this issue.Increased inspections will be performed and additional training will be implemented with all personnel.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends h3 other text : see manufacturer narrative.

• Brand Name: PLEURX DRAINAGE KIT 500ML
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 11322529
• Report Number: 9680904-2021-00014
• Device Sequence Number: 4125256
• Product Code: DWM
• UDI-Device Identifier: 10885403229435
• UDI-Public: (01)10885403229435
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: Lay User/Patient
• Device Expiration Date: 09/13/2022
• Device Model Number: 50-7205B
• Device Catalogue Number: 50-7205B
• Device Lot Number: 0001352657
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other