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

Catalog Number	50-7245A
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	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Description of the problem (what / why) - glue line between the tube and the connector does not hold.How often did the defect occur - 1.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes.Safety problem - no.Problem solved - yes.How was the problem resolved / additional information - replace.Photo / sample available - no.Safety valve broken / damaged / defective - no information / not applicable.Safety clamp open if valve broken./ damaged./ d.- no information / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-7245a.Procedure performed by - patient.Performed in - home.Additional information - none / not relevant.Received answers - (b)(6) 2023.Please answer the following questions: -could you please provide a further description of the issue? "glue line between the tube and the connector does not hold." - no further information available, the complained lockable drainage line is currently being sent back to us.- was there any component disconnected/ broken? - no further information available - what was the impact to the patient? - effusion leaked out.
Additional Manufacturer Narrative
Pr 8613011 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
Description of the problem (what / why) - glue line between the tube and the connector does not hold.How often did the defect occur - 1.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes.Safety problem - no.Problem solved - yes.How was the problem resolved / additional information - replace.Photo / sample available - no.Safety valve broken / damaged / defective - no information / not applicable.Safety clamp open if valve broken./ damaged./ d.- no information / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-7245a.Procedure performed by - patient.Performed in - home.Additional information - none / not relevant.Please answer the following questions: could you please provide a further description of the issue? "glue line between the tube and the connector does not hold." - no further information available, the complained lockable drainage line is currently being sent back to us.Was there any component disconnected/ broken? - no further information available what was the impact to the patient? - effusion leaked out.
Additional Manufacturer Narrative
Pr 8613011 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, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see manufacture narration.
Event or Problem Description
Description of the problem (what / why) - glue line between the tube and the connector does not hold.How often did the defect occur - 1 medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes safety problem - no problem solved - yes how was the problem resolved / additional information - replace.Photo / sample available - no safety valve broken / damaged / defective - no information / not applicable.Safety clamp open if valve broken./ damaged./ d.- no information / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - 2023-08-03 where is the catheter located: in the abdomen or chest? - abdomen connected device (pleurx/peritx/brand) - 50-7245a procedure performed by - patient performed in - home additional information - none / not relevant received answers - 14 aug 2023 please answer the following questions: -could you please provide a further description of the issue? "glue line between the tube and the connector does not hold." - no further information available, the complained lockable drainage line is currently being sent back to us.- was there any component disconnected/ broken? - no further information available - what was the impact to the patient? - effusion leaked out.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one lockable drainage line sample was received by our quality team for investigation.Upon visual inspection of the sample, it was observed that the access dilator disconnected from the drainage line.The drainage line has the mark of adhesive which indicates it was inserted into the adhesive dispenser; therefore, the reported failure mode was confirmed.A device history record could not be evaluated as the lot number is unknown.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.

• Brand Name: LOCKABLE DRAINAGE LINE
• 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: 17595561
• Report Number: 9680904-2023-00029
• Device Sequence Number: 7420797
• Product Code: DWM
• UDI-Device Identifier: 10885403502385
• UDI-Public: (01)10885403502385
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2023

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 Catalogue Number: 50-7245A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 10/06/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 08/31/2023; 10/06/2023
• 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