MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7000B
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records has not been performed.The device was not returned.The investigation is currently underway.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that the weight of the fluid filled bag pulled the catheter out verbatim: catheter was connected to a bag utilizing a stopcock; the weight of the fluid filled bag pulled the catheter out.
Event or Problem Description
Material # 50-7000b.Batch # unknown.It was reported that the catheter was connected to a bag utilizing a stopcock and the weight of the fluid filled bag pulled the catheter out of the patient and requiring replacement of a new catheter.Verbatim: - catheter was connected to a bag utilizing a stopcock.- the weight of the fluid filled bag pulled the catheter out.Customer response on (b)(6) 2024 for follow-up 2.This is what the customer was able to answer.White cap would not adapt to the catheter no harm to patient, however, was charged for a full kit in order to get another white cap no injury i do not have a lot number, including mary lynn here in case she has that information.¿hi¿i do not have the lot information; basically, nursing was having to open up a whole kit as the white cap was broken¿.Customer response on (b)(6) 2024.Was there any damage or visible defect with the cap? the white cap would not attach to the catheter.Uncertain if visible damage was noticed.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? this happened when attempting to attach a cap to a patients catheter is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address.No.Where is the catheter located? abdomen or chest.Reported as pleurx which is indicated for chest.Total number of occurrences associated with defective cap issue.(b)(4) reported.Was the catheter used is a bd product (pleurx / peritx) catheter?.
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records was not performed.Investigation summary: the sample was unavailable for analysis.It was communicated that something other than the access dilator, provided by bd, was connected to the catheter.This represents a misuse issue.The defective cap reported issue was not able to be confirmed since the cap was not returned for physical evaluation.However, molding issue is under investigation to determine a root cause and correct it.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PLEURX PLEURAL CATHETER KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20859817
• Report Number: 1625685-2024-00138
• Device Sequence Number: 4058536
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7000B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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