MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRINAGE KIT 1000 ML; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7510

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the valve and insertion pin are connected, liquid escapes from the valve after i dripped quite a bit of liquid.No leakage when i previously removed the valve cap and no leakage when i removed the access top.I used a new bottle and it worked perfectly with no leaks.- where did leakage occurred? > when the access tip connected with the valve.Between access tip and valve.When removed the access tip, there is no leakage.- is this 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, there was fully clicked.- did the leakage occurred to the drainage line to the bottle? > no.- was there damage noted on the access tip or patient's valve.> no.- where is the catheter located? > this information is not known to us.- is there a sample available showing the reported issue? > the sample is on the way to ewimed.It hasn't arrived yet.

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 number 0001382390 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.

Event Description

When the valve and insertion pin are connected, liquid escapes from the valve after i i dripped quite a bit of liquid.No leakage when i previously removed the valve cap and no leakage when i removed the access top.I used a new bottle and it worked perfectly with no leaks.- where did leakage occurred? > when the access tip connected with the valve.Between access tip and valve.When removed the access tip, there is no leakage.- is this 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, there was fully clicked.- did the leakage occurred to the drainage line to the bottle? > no.- was there damage noted on the access tip or patient's valve.> no.- where is the catheter located? > this information is not known to us.- is there a sample available showing the reported issue? > the sample is on the way to ewimed.It hasn't arrived yet.

• Brand Name: PLEURX DRINAGE KIT 1000 ML
• 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: 14322112
• MDR Text Key: 299836662
• Report Number: 9680904-2022-00022
• Device Sequence Number: 1
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 50-7510
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001382390
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• 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