MAUDE Adverse Event Report: PLEURX LOCKABLE DRAINAGE LINE SET - 50-7245 - CRACKED; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7245
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that there is a crack in the tubing when patients come back from ir.There have been more than 3 failures on the lockable drainage line tubing in the last 2 days.They are having trouble with a crack in this tubing when patients come back from ir and has affected 3 different departments if not more.It cracks at the base of the lock when it attaches to the pleurx drain.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: two photo samples were provided to our quality team for evaluation.Through visual inspection, the photos display the product label, confirming the reported product.There was no physical sample or photos provided that show any defect with the tubing therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the lot 0001296186 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.Complaints received for this device and defect will continue to be monitored for future occurrences.
Event or Problem Description
It was reported that there is a crack in the tubing when patients come back from ir.There have been more than 3 failures on the lockable drainage line tubing in the last 2 days.They are having trouble with a crack in this tubing when patients come back from ir and has affected 3 different departments if not more.It cracks at the base of the lock when it attaches to the pleurx drain.

• Brand Name: PLEURX LOCKABLE DRAINAGE LINE SET - 50-7245 - CRACKED
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 11597129
• Report Number: 9680904-2021-00030
• Device Sequence Number: 19706886
• Product Code: DWM
• UDI-Device Identifier: 10885403174872
• UDI-Public: (01)10885403174872
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 03/08/2024
• Device Model Number: 50-7245
• Device Catalogue Number: 50-7245
• Device Lot Number: 0001296186
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other