MAUDE Adverse Event Report: CAREFUSION, INC PLEURX LOCKABLE DRAINAGE LINE SET; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7245
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	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During drainage of pleurx (50-7050), the patient made a sudden move, and the plastic valve of the drainage line set got detached from the line.3 different events, same lot no.In one event, air got into the body-patient was drained immediately.- was the access tip disconnected from drainage line, if yes - did the access tip remains in the patient valve? yes, in the incidence on the (b)(6) it remained within and i could very distinctly hear the air entering the lung.Was able to immediately kink the tube and put the clamp there to close the tube.- what was the patient impact for event one two and three? in case one the nurse closed the tube at once.The patient was connected to the emerson-vacuum system.The doctor checked the patient and the saturation was 97%, plus an x-ray was done.There was no pneumothorax and the patient was reported to feeling well.Case 2: 25th december the report only states that the connector broke and the patient was reconnected case 3: 27th december that was the day i was present and as reported above we reconnected the patient as quickly as possible to the vacuum and reported the incidenc to the doctor who ordered a chest x-ray that was ok.- per description "the patient made a sudden move, and the plastic valve of the drainage line set got detached from the line" what was the patient impact? the patient had moved so that the tube was under tension and in the incidence where i was present the tip just came out of the tube and left the valve open.The patient seemed fine and had no problems breathing.It was possible to at once close the tube the moment the sound of air being aspirated became evident.(case 3) - please provide event occurrence dates.23rd, 25th and 27th december 2022 - air got into the body-patient - was there any medical intervention required? the patient was already connected to the emerson and so any aspirated air could be removed immediately.No further interventions were needed as the patient did not have any recorded problems after the episodes.- where is the catheter located? abdomen or chest, right side was there any leakage? yes, there was a stubborn leakage at the ex-site of the pleurx and that was the reason the patient had originally been connected to the vacuum-system.How was the issue resolved? the patient remained connected to the vacuum-system until the skin closed and the leakage stopped.Did they able to drain successfully yes, the patient was later on successfully drained in the conventional way with a regular drainage set.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0501, patient problem code: f26.
Event or Problem Description
During drainage of pleurx (50-7050), the patient made a sudden move, and the plastic valve of the drainage line set got detached from the line.3 different events, same lot no.In one event, air got into the body-patient was drained immediately.Pir with aeq available in the attachments below.Pictures available in the attachments below.Was the access tip disconnected from drainage line, if yes - did the access tip remains in the patient valve? yes, in the incidence on the 27th december it remained within and i could very distinctly hear the air entering the lung.Was able to immediately kink the tube and put the clamp there to close the tube.What was the patient impact for event one two and three? in case one the nurse closed the tube at once.The patient was connected to the emerson-vacuum system.The doctor checked the patient and the saturation was 97%, plus an x-ray was done.There was no pneumothorax and the patient was reported to feeling well.Case 2: 25th december the report only states that the connector broke and the patient was reconnected case 3: 27th december that was the day i was present and as reported above we reconnected the patient as quickly as possible to the vacuum and reported the incidenc to the doctor who ordered a chest x-ray that was ok.Per description "the patient made a sudden move, and the plastic valve of the drainage line set got detached from the line" what was the patient impact? the patient had moved so that the tube was under tension and in the incidence where i was present the tip just came out of the tube and left the valve open.The patient seemed fine and had no problems breathing.It was possible to at once close the tube the moment the sound of air being aspirated became evident.(case 3).Please provide event occurrence dates.23rd, 25th and 27th december 2022.Air got into the body-patient - was there any medical intervention required? the patient was already connected to the emerson and so any aspirated air could be removed immediately.No further interventions were needed as the patient did not have any recorded problems after the episodes.Where is the catheter located? abdomen or chest, right side.Was there any leakage? yes, there was a stubborn leakage at the ex-site of the pleurx and that was the reason the patient had originally been connected to the vacuum-system.How was the issue resolved? the patient remained connected to the vacuum-system until the skin closed and the leakage stopped.Did they able to drain successfully yes, the patient was later on successfully drained in the conventional way with a regular drainage set tracking number for sample return.The lot number was: 0001458808.*i am following-up for the lot number connected to each event, as another one was previously provided, and for tracking number - will update main pr once known.22- january- 2023 - do you know the effected lot numbers? - lot # 0001472068.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: three photos and ten sample were provided to our quality team for investigation.The failure mode of disconnected access tip could be confirmed through a picture provided which showed the drainage line without the access tip.However, ten physical samples were also returned and a visual inspection and pull test were performed in which no issues were observed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001472068 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 manufacture narration.

• Brand Name: PLEURX LOCKABLE DRAINAGE LINE SET
• 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: 16240552
• Report Number: 9680904-2023-00003
• Device Sequence Number: 12402662
• Product Code: DWM
• UDI-Device Identifier: 10885403174872
• UDI-Public: (01)10885403174872
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K141965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-7245
• Device Catalogue Number: 50-7245
• Device Lot Number: 0001472068
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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