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

Catalog Number	50-7500B
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Alcohol pad dry date: (b)(6) 2024.Injury (patient/other): no product possible involved in injury: no product available for inquiry: no fixed location: 2 - when used origin: patient complaint: alcohol pad dry.Product: item no.: 50-7500b/v001 - pleurx¿ drainage set, 500 ml reservoir incl.Accessories pu (packaging unit) 2(b)(4) pieces item no.: 50-7510/v001 - pleurx¿ drainage set, 1000 ml, incl.Accessories pu (packaging unit) (b)(4) pieces lot no.: 0001477528; 0001554159; 0001551811.Information on the error pattern: fault location: alcohol swab error type: dry.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0201 patient problem code: f26.H10 - multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001554159 medical device expiration date: 2026-08-03 device manufacture date: 2024-02-15 medical device lot #: 0001551811 medical device expiration date: 2026-07-19 device manufacture date: 2024-01-31 h11: section a through f ¿ the information provided 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.
Additional Manufacturer Narrative
H10: pr 10973981 follow-up emdr for device evaluation: 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 numbers 0001554159, 0001551811 were 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.During the incoming inspection process, the applicable inspection procedure requires a functional inspection in which is verified that the pads are wet with alcohol.No issues were found regarding the inspections for the applicable lot.This component is bought to a supplier and is not physically or chemically changed in any way in the dr facility.It is just manually placed in the procedure pack; therefore, it is thought that the probable root cause relies on the supplier.However, supplier of the component has been changed, and no quality issues have been reported since the change of supplier.Based on the available information we are not able to identify a root cause at this time.H11 - corrected information -site legal name (fda) updated to carefusion d.R.203ltd.-santo domingo, dominical republic.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
Alcohol pad dry injury (patient/other): no product possible involved in injury: no product available for inquiry: no fixed location: 2 - when used origin: patient complaint: alcohol pad dry information on the error pattern: fault location: alcohol swab error type: dry could you please provide total number of occurrences associated with reported lot numbers 0001554159, 0001551811.- no other complaints reported is there a photo or sample available showing the reported issue?- no.

• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20604491
• Report Number: 1625685-2024-00118
• Device Sequence Number: 12627172
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714(11)240131(17)260719(10)0001551811
• 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,Followup
• Report Date (Section B): 01/08/2025

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: 07/19/2026
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001551811
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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
• Patient Sex: Unknown