MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Access tip damaged.Medical intervention (other than first aid): no.Needle/probe stick: no.Other actions taken: no.Safety issue: nein.Issue resolved: ja.How issue resolved / additional information: replacement.Photo / sample available: nein.Safety valve broken / damaged / disconnected: no.Safety clamp open, when valve broke/damaged/disconnected: no.Safety valve nose broken / damaged: no.Locking tab broken / damaged: no.Leakage: no.Successful drainage: ja.Impact to patient: no indication for that / not applicable.Exposure to blood / bodily fluid: no.Course of treatment changed due to event: no.Time catheter in place: see the list.Connected device (pleurx/peritx/brand) see the list.Procedure performed by: end user / lay person.Additional information: the palettes are loaded / stored in the same way as bd delivers them.No pallets are stacked.We do not know how the bottles are stored at the patient.(b)(6): (b)(6)2024: 1st follow-up comments (rec) could you please provide a further description of the issue? - no vacuum.Was it the access tip was cracked? - not known.Was the issue identified before use and the product discarded or did, they identify during use? - detected during use.Where is the catheter located? abdomen or chest - not known.What was the impact to the patient? - had to use a replacement.Was there leakage noticed to the access tip and the patient valve - not known.Could you please provide lot number for the unknown lot (mat# 50-7500b) - not known.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.Device problem code: a0401.Patient problem code: f26.H10: d4 (expiration date: 07/2026) no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001550321 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.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20517918
• Report Number: 9680904-2024-00023
• Device Sequence Number: 15394859
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(11)240119(17)260707(10)0001550321
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 07/07/2026
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001550321
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown