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

Catalog Number	50-7500B
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records currently underway.The device was not returned.The investigation is currently underway.H10: pma-510k: k160437, k160450, k201155, k971753, d2, pro code dwm, png.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
Material no: 50-7500b batch no: 0001567492.It was reported that the access tip was cracked.There was no patient harm.Verbatim: it was reported: customer received kit with defective issue; no pt harm.Event description states: ¿defective cap¿.Rcc received a complaint via email.Could you please provide a further description of the issue? 2 kits had access tip was cracked /1 kit had a dried alcohol pad according to customer all from same lot.Was there any damage or visible defect with the cap? to the access tip leakage did occur on one of the two cracked access tips, the other was caught before.What was the impact to the patient? no.Did the issue happen during patient use? yes during draining if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? is there a photo or sample available showing the reported issue? no if yes, please provide mailing address and email address.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number for the device was provided, and a device history record was performed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Product was inspected during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.H10: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.Based on the available information we are not able to identify a root cause at this time.H10: pma / 510k: k160437, k160450, k201155, k971753; d2 pro code dwm, png.H10: b5, e1, g4, g7, h2, h6 (component code).H11: h6 (type of investigation, investigation results, and investigation conclusions) 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 that the access tip was cracked.There was no patient harm.Verbatim: it was reported: customer received kit with defective issue; no pt harm event description states: ¿defective cap¿ rcc received a complaint via email.Email(s) attached.- could you please provide a further description of the issue? 2 kits had access tip was cracked /1 kit had a dried alcohol pad according to customer all from same lot - was there any damage or visible defect with the cap? to the access tip leakage did occur on one of the two cracked access tips, the other was caught before.- what was the impact to the patient? no - did the issue happen during patient use? yes during draining if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? - is there a photo or sample available showing the reported issue? no if yes, please provide mailing address and email address.

• 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: 21011566
• Report Number: 1625685-2024-00150
• Device Sequence Number: 8191434
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714(11)240507(17)261024(10)0001567492
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: Lay User/Patient
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001567492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown