MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 500ML 10/CS; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7500B
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2022
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 access tip has a hole.Verbatim: just got another defective plurex kit.White tip has a hole in it.This makes number 4.I think we would like you to send us 4 replacement kits.My mom's name is (b)(6) dob (b)(6) 1935.Her address is /omit/.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos were provided to our quality team for investigation.Through visual inspection, it was observed that there is a hole in the access tip therefore, the reported failure mode was confirmed.The bottle cannot be seen in the picture; therefore, it cannot be confirmed whether the bottle was used.The photo displays the product label, confirming the reported product.A review of the internal manufacturing device records and raw material history files for reported lots 0001410299 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.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 manufacture narration.
Event or Problem Description
It was reported that access tip has a hole.Verbatim: just got another defective plurex kit.White tip has a hole in it.This makes number 4.I think we would like you to send us 4 replacement kits.My mom's name is (b)(6) dob (b)(6).Her address is /omit/.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14176515
• Report Number: 9680904-2022-00019
• Device Sequence Number: 17714881
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: 09/13/2023
• Device Model Number: 50-7500B
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001410299
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/05/2022
• 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
• Patient Sex: Unknown