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

Model Number 50-7500B

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.Please confirm the awareness date, per (b)(4)awareness date is (b)(4) 2021, (b)(6) 2021 (yyyy-mm-dd).What is reason for late awareness? our queries to the employees and internal documentation was on (b)(6) 2022 (yyyy-mm-dd).Please confirm event occurrence date.Per patient information grid event occurrence date is (b)(6) 2022.Please see the answers above.Did the leakage occurred at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? yes, the access tip fully engaged the valve.Was there damage noted on the access tip or patient's valve.Unfortunately this cannot be answered.Patient has received further shipments to date.Error no longer occurred.Where is the catheter located? chest.Is there a sample available showing the reported issue? the patient discarded the product.What is the lot number associated with reported issue? according to delivery tracking, it should be lot 0001377022.Valve is tight.There was never any hazard to the patient.This is a known defect.

Event Description

Valve drips when access tip is connected.If none is connected, the valve is tight.The access tip might be the problem here.- please confirm the awareness date, per tw awareness date is 12/02/2021.> 2021-12-02 (yyyy-mm-dd) - what is reason for late awareness? > our queries to the employees and internal documentation was on (b)(6) 2022 (yyyy-mm-dd) - please confirm event occurrence date.Per patient information grid event occurrence date is (b)(6)2022.> please see the answers above - did the leakage occurred at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? > yes, the access tip fully engaged the valve - was there damage noted on the access tip or patient's valve.> unfortunately this cannot be answered.Patient has received further shipments to date.Error no longer occurred.- where is the catheter located? > chest - is there a sample available showing the reported issue? > the patient discarded the product.- what is the lot number associated with reported issue? > according to delivery tracking, it should be lot 0001377022 the occurrence date was (b)(6), 2021.The awareness date was december 2nd, 2021.This complaint was immediately evaluated by us.Valve is tight.There was never any hazard to the patient.This is a known defect.Subsequent requests for samples or photos could not be provided.

Manufacturer Narrative

Pr 4351240 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 number 0001377022 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.Based on the available information we are not able to identify a root cause at this time.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.H3 other text : see manufacturer here.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• Type of Device: 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: 13424013
• MDR Text Key: 288902897
• Report Number: 9680904-2022-00003
• Device Sequence Number: 1
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 50-7500B
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001377022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other