MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number 50-7510

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(4).

Event Description

The tube disconnected from the bottle during use.Was the drainage line disconnected from the bottle at any point during the drain or was it noticed prior to drainage? > yes, it says so in the description and in the pir form under point 7.If it's before use and did they attempt to reconnect it? > during use.Need to verify the line was disconnected prior to use and the bottle was not used.> during use.Was the clamp properly closed until after the plunger was pressed > our patients receive detailed training before the first application.The process should have been performed correctly.Where is the catheter located? abdomen or chest > abdomen.Is there a photo or sample available showing the reported issue? > there are no samples available.What was the impact to the patient? > no impact.

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 lot 0001394691 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections throughout manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Assembly of the drainage line onto the spike is performed manually.Once the adhesive is applied onto the drainage line, it is then connected onto the spike and personnel must hold the junction before the product moves onto the next stage of assembly.During our investigation it was identified that personnel were not following proper procedure after applying the adhesive onto the drainage line.Based on the quality team's investigation, it was determined that the disconnected drainage line was likely due to personnel not following procedure.Manufacturing personnel have been notified of this incident and additional training was provided.Complaints received for this device and defect will continue to be monitored for future occurrences.H3 other text: see manufacturer here.

Event Description

The tube disconnected from the bottle during use.Was the drainage line disconnected from the bottle at any point during the drain or was it noticed prior to drainage? yes, it says so in the description and in the pir form under point 7.If it's before use and did they attempt to reconnect it? during use.Need to verify the line was disconnected prior to use and the bottle was not used.During use.Was the clamp properly closed until after the plunger was pressed our patients receive detailed training before the first application.The process should have been performed correctly.Where is the catheter located? abdomen or chest: abdomen.Is there a photo or sample available showing the reported issue? there are no samples available.What was the impact to the patient? no impact.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 13442997
• MDR Text Key: 288901177
• Report Number: 9680904-2022-00007
• Device Sequence Number: 1
• Product Code: PNG
• 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: 02/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: 50-7510
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001394691
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/14/2022
• 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