MAUDE Adverse Event Report: PLEURX VACUUM BOTTLE 1000ML; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7210
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Today, i would like to point out a problem that i have noticed several times on the pleurx devices, the bad fixing of the tubing on the bottle itself.When you realize this before you put the suction on, we can push it back and the vacuum will not go out.Lot number is 0001347542.30nov2020: email sent requesting if additional response has been received.Per customer response; at least 2 times, tubing disconnected from the base on the bottle, and once by pushing it back before vacuuming the drainage could take place with good suction, (copy given back to the dr (b)(6) pharmacy) no incidence on the care, no patient damage.This was established before connecting the vacuum device to the patient.It is a thoracic pleurx.
Event or Problem Description
Today, i would like to point out a problem that i have noticed several times on the pleurx devices, the bad fixing of the tubing on the bottle itself.When you realize this before you put the suction on, we can push it back and the vacuum will not go out.Lot number is 0001347542.30nov2020: email sent requesting if additional response has been received.Per customer response; at least 2 times, tubing disconnected from the base on the bottle, and once by pushing it back before vacuuming the drainage could take place with good suction, (copy given back to the dr (b)(6) pharmacy) no incidence on the care, no patient damage this was established before connecting the vacuum device to the patient.It is a thoracic pleurx.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: one photo sample was provided to our quality team for investigation.Through visual inspection, the drainage lines appears to be connected to the top of the bottle, therefore the reported failure could not be confirmed.A review of the internal manufacturing device records and raw material history files for the lot 0001347542 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Assembly of the drainage line onto the spike is performed manually.Once the adhesive is applied onto the drainage line, it is then connected onto the spike and personnel must hold the junction before the product moves onto the next stage of assembly.During our investigation it was identified that personnel were not following proper procedure after applying the adhesive onto the drainage line and were moving the product without holding the connection for the appropriate amount of time.Additionally, we identified that preventative maintenance was not properly performed on one of the machines which adheres the drainage line to the spike.Based on the quality team's investigation, it was determined that the disconnected drainage line was likely due to both personnel not following procedure and manufacturing equipment.Manufacturing personnel have been notified of this incident and additional training was provided.Updates will be implemented to ensure the proper maintenance is performed on the manufacturing equipment.Complaints received for this device and defect will continue to be monitored for future occurrences.H3 other text : see manufacturer narrative.

• Brand Name: PLEURX VACUUM BOTTLE 1000ML
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 10991342
• Report Number: 1423507-2020-00061
• Device Sequence Number: 3478628
• Product Code: DWM
• UDI-Device Identifier: 10885403090660
• UDI-Public: (01)10885403090660
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: 50-7210
• Device Catalogue Number: 50-7210
• Device Lot Number: 0001347542
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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