MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 500ML 10/CS - 50-7500B; APPARATUS, SUCTION, PATIENT CARE

Model 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	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0201.Patient problem code: f26.Two lot number: medical device lot #: 0001460729, medical device expiration date: 2024-10-11, device manufacture date: 2022-04-25.Medical device lot #: 0001464175, medical device expiration date: 2024-09-20, device manufacture date: 2022-04-04.
Event or Problem Description
Description of the problem (what / why) - alcohol wipe dry.How often did the defect occur - 10.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes.Safety problem - no.Problem solved - ja.How was the problem resolved / additional information - replace.Photo / sample available - no.Safety valve broken / damaged / defective - no information / not applicable.Safety clamp open if valve broken./ damaged./ d.- no information / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - chest.Connected device (pleurx/peritx/brand) - 50-7500b.Procedure performed by - patient.Performed in - home.Additional information - none / not relevant.
Additional Manufacturer Narrative
(b)(4) 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 0001464175and 0001460729 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.Based on the quality team's investigation, it was identified that the probable root cause of the issue corresponds to a supplier defect.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,.A quality notification was sent to the supplier.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Description of the problem (what / why) - alcohol wipe dry.How often did the defect occur - 10 medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes safety problem - no problem solved - ja how was the problem resolved / additional information - replace.Photo / sample available - no safety valve broken / damaged / defective - no information / not applicable.Safety clamp open if valve broken./ damaged./ d.- no information / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - 2023-01-31 where is the catheter located: in the abdomen or chest? - chest connected device (pleurx/peritx/brand) - 50-7500b procedure performed by - patient performed in - home additional information - none / not relevant 0,8 ve lot 0001460729.0.2 ve lot 0001464175.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS - 50-7500B
• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17321377
• Report Number: 9680904-2023-00023
• Device Sequence Number: 17877867
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K971753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 10/11/2024
• Device Model Number: 50-7500B
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001464175
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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