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

Catalog Number	50-7000B
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
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: f27.H10: d4 (expiration date: 07/2026) month and year.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported by customer that 2 each of item: 50-7000b had water damage when delivered.Rcc received a complaint via community.The customer called in and reported that item 2 each of item: 50-7000b had water damage when delivered.They are requesting a return and credit.1.Could you please provide a further description of the issue? item shows water stains on the package.2.What was the impact to the patient? no.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.4.Can you please provide the lot number associated with reported issue? 0001582626.5.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2024.6.Are you able to provide photos of the damaged items? yes.7.Can you describe the external condition of the box upon receipt, any signs of mishandling? i can not.8.Did you notice any unusual sounds or shifting inside the box when handling it? no.9.Can you describe any damage found to the items inside (including quantity/cases/shelf pack affected?) no, we did not open the product.10.Could you please confirm if there is any issue with product or this is a service issue? i cannot, end user stated that they could not guarantee the sterility of the item.
Additional Manufacturer Narrative
H10: (b)(4) follow-up emdr for device evaluation: three photos sample were provided to our quality team for evaluation.Through visual inspection, it was observed that the two trays pictured have sustained significant damage; therefore, the reported failure mode was confirmed.We are unable to confirm a sterile barrier breach or determine how the product was damaged.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001582626 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 and there was no damage or deviations reported.Based on the available information we are not able to identify a root cause at this time.Distribution has been notified of the failure.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.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 2 each of item 50-7000b had water damage when delivered.Verbatim: rcc received a complaint via community.The customer called in and reported that item 2 each of item 50-7000b had water damage when delivered.They are requesting a return and credit.1.Could you please provide a further description of the issue? item shows water stains on the package.2.What was the impact to the patient? no.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.4.Can you please provide the lot number associated with reported issue? 0001582626.5.Can you please provide an exact date of event in format dd-mmm-yyyy? 10/04/2024.6.Are you able to provide photos of the damaged items? yes.7.Can you describe the external condition of the box upon receipt, any signs of mishandling? i can not.8.Did you notice any unusual sounds or shifting inside the box when handling it? no.9.Can you describe any damage found to the items inside (including quantity/cases/shelf pack affected?) no, we did not open the product.10.Could you please confirm if there is any issue with product or this is a service issue? i cannot, end user stated that they could not guarantee the sterility of the item.

• 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: 20516245
• Report Number: 1625685-2024-00114
• Device Sequence Number: 8559434
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971(11)240812(17)260731(10)0001582626
• 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): 11/22/2024

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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001582626
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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