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

Catalog Number	50-7700
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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.Device problem code: a0205.Patient problem code: f26.H10: d4 (expiration date: 12/2026).H10: the lot number for the device was provided.The device history records are currently under review.Photos were provided and review is currently underway.The device is pending return.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 box was delivered wet along with the product on the inside.Verbatim: rcc received a complaint via email.Email(s) attached.I am wanting to do a return for (1ea) kit cath pleural starter 1000 ml.The box was delivered wet along with the product on the inside.Ref #(b)(4).
Additional Manufacturer Narrative
H10: three photos and one sample were provided to our quality team for investigation.Through visual inspection, we can confirm that the outer packaging is wet (or at one point was wet and is damaged).A review of the internal manufacturing device records and raw material history files for the reported lot number 0001601080 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.The sterilization record was reviewed, no damage was reported.The distribution center has been notified of this failure.Based on the available information we are not able to identify a root cause at this time.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 box was delivered wet along with the product on the inside.Verbatim: rcc received a complaint via email.Email(s) attached.I am wanting to do a return for (1ea ) kit cath pleural starter 1000ml.The box was delivered wet along with the product on the inside.Ref# 50-7700.

• Brand Name: PLEURAL CATHETER AND STARTER 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: 21315879
• Report Number: 1625685-2025-00012
• Device Sequence Number: 18283815
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520(11)241206(17)261231(10)0001601080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Catalogue Number: 50-7700
• Device Lot Number: 0001601080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown