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

Model Number	50-7000B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no: 50-7000b, batch no: 0001402210.¿ it was reported that the dilator and peel-away introducer did not lock in place prior to insertion into the patient's chest and had to be immediately removed.¿ the dilator and peel-away introducer was faulty.It did not lock in place prior toinsertion into the patient's chest.It immediately had to be removed.There is a piece that locks the dilator inplace and it is missing on this item.This is an item that is not packaged separately so a new kit had to be opened while the patient's chest had already been incised in preparation for catheter insertion.What was the original intended procedure? : indwelling pleural catheter placement what problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do;b 7 other relevant history, including preexisting medical conditions (e g, allergies, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc) (continued)concomitant medical products and therapy dates (exclude treatment of event).On (b)(6) 2021 - lvm requesting clarification of defective issue - left contact information ack pending.
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 number 0001402210 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.Complaint investigation was unable to confirm the reported failure mode through review of the device batch records.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.
Event or Problem Description
Material no: 50-7000b.Batch no: 0001402210.  it was reported that the dilator and peel-away introducer did not lock in place prior to insertion into the patient's chest and had to be immediately removed.  verbatim: describe the event or problem: the dilator and peel-away introducer was faulty.It did not lock in place prior to insertion into the patient's chest.It immediately had to be removed.There is a piece that locks the dilator in place and it is missing on this item.This is an item that is not packaged separately so a new kit had to be opened while the patient's chest had already been incised in preparation for catheter insertion.What was the original intended procedure? : indwelling pleural catheter placement.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do; 29jun21 - lvm requesting clarification of defective issue - left contact information.01jul21 - sent ack email.

• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12142600
• Report Number: 1625685-2021-00046
• Device Sequence Number: 3864961
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001402210
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 12/10/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Unknown