MAUDE Adverse Event Report: PLEURX DRAINAGE KIT 1000ML - 50-7510; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7510

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).See manufacture narration.

Event Description

Material no: 50-7510.Batch no: 0001387892.¿ it was reported: customer received kit with leaking at the connection point defective issue; no pt harm.Event description states: leaking at the connection poin ¿questions/inquiries: confirm patient harm and notate in event desc per attached statement above please reach out and request to verify the following: where did leakage occurred? at the access tip to catheter.Is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? yes at the access tip to catheter.Did the leakage occurred to the drainage line to the bottle? was there damage noted on the access tip or patient's valve.Yes bent.Where is the catheter located? at 1:00pmcst 27may21 - spoke to customer - has sample avail referred to in email attached - after plunger engaged and roller released the leaking takes place at the access tip/catheter connection - noticed at times that the access tip appears to be bent -customer explained that he kept samples of the affected bottles and is ready to send them - asked that we send labels - no pt harm.

Manufacturer Narrative

Pr 2912104 follow-up emdr for device evaluation: one sample of lot 0001387892 was provided to our quality team for investigation.Through visual inspection, it was observed cracked on surface of access tip and leakage occurred because of the cracked on the access tip, therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for reported lots 0001387892 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.While we did not identify a direct issue, a corrective action project was opened to further investigate these defects.Through our investigation, we identified the defect can be produced due to pins in the access dilator mold becoming bent during production.Improvements are in the process of being implemented to ensure that repairs and maintenance orders are in alignment with established documentation processes, allowing for robust verification of the condition of the mold.Actions have been taken to assess and replace bent pins within the mold for the access dilator.Improved inspections and additional personnel training have been implemented.In addition, enhanced preventative maintenance procedures are currently being added to the process.

Event Description

Material no: (b)(4).Batch no: 0001387892   it was reported: customer received kit with leaking at the connection point defective issue; no pt harm ¿ event description states: leaking at the connection poin  questions/inquiries: -confirm patient harm and notate in event desc per attached statement above please reach out and request to verify the following: - where did leakage occurred? - at the access tip to catheter - is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? - yes at the access tip to catheter - did the leakage occurred to the drainage line to the bottle? - was there damage noted on the access tip or patient's valve.- yes bent - where is the catheter located? 1:00pmcst (b)(6)2021 - spoke to customer - has sample avail referred to in email attached - after plunger engaged and roller released the leaking takes place at the access tip/catheter connection - noticed at times that the access tip appears to be bent - customer explained that he kept samples of the affected bottles and is ready to send them - asked that we send labels - no pt harm.

• Brand Name: PLEURX DRAINAGE KIT 1000ML - 50-7510
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 11952535
• MDR Text Key: 267352180
• Report Number: 9680904-2021-00061
• Device Sequence Number: 1
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (y/n): N
• PMA/PMN Number: K160450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Model Number: 50-7510
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001387892
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other