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

Catalog Number	50-7700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f1905.
Event or Problem Description
It was reported by customer that no fluid was coming out from the valve, but fluid coming out around the insertion site.Ir did flouro and noticed that the catheter had separated 1 cm below the cuff.Verbatim: after placing pleurx catheter, item code 50-7000b, no fluid was coming out from the valve, but fluid coming out around the insertion site.Ir did flouro and noticed that the catheter had separated 1 cm below the cuff.Per the team, they did not notice any defect prior to placing or during tunneling.The broken portion of the catheter was in the tunnel track so it was easily retrieved.They removed the two catheter pieces and replaced with a new pleurx catheter.Additional information received on 04sep.1.When was this defect observed? during or before use? was not observed during case or before, catheter appeared to not to have any defects, found it on fluoro post placement 2.What was the impact to the patient? no harm, just delay in care, they opened another pleurx tray and inserted the new pleurx catheter with no issues.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None, just delay, see note above 4.Provided material# 50-7000b doesn't match our records for lot# 0001568480.Can you please check if it is a typo and provide the material number and lot number of the product associated with reported issue? item code is 50-7700.Additional information received on 12sep.1.Was the catheter broken during the catheter insertion procedure? yes, when they finished the procedure, they noticed under fluoro that the catheter had broke 2.How long has the catheter been in place ¿ patient was still on the procedure table, catheter was in place maybe 1 to 2 minutes, they were doing their post placement fluoro scan to verify placement.3.Was the place where the catheter broke internal to the body, or was the catheter broken in the external portion? internal ¿ under the skin along the tunneled path to the pleural space (not in the pleural space).4.Where is the catheter located? abdomen or chest ¿ was the chest ¿ it was immediately removed when they discovered it had broken.
Additional Manufacturer Narrative
H10: (b)(4) follow-up emdr for device evaluation: one catheter and orange stylet were received to our quality team for investigation.Through visual inspection, broken tubing observed; therefore, the reported failure could be verified.An orange stylet was inserted through the valve, this is not an approved access method.Per the instructions for use, "drainage procedure - the drainage can be performed using: a) pleurx vacuum bottle(s) b) lockable drainage line with glass vacuum bottle(s) or with wall suction." the inner valves keep fluid from flowing out, unless accessed using access dilator as stated per the instructions for use.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001568480 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.Tubing properties, including tensile strength and elongation are provided by the vendor and reviewed at incoming, no issues were observed.Based on the available information we are not able to identify a root cause at this time regarding the broken tubing.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that no fluid was coming out from the valve, but fluid coming out around the insertion site.Ir did flouro and noticed that the catheter had separated 1 cm below the cuff.Verbatim: after placing pleurx catheter, item code 50-7000b, no fluid was coming out from the valve, but fluid coming out around the insertion site.Ir did flouro and noticed that the catheter had separated 1 cm below the cuff.Per the team, they did not notice any defect prior to placing or during tunneling.The broken portion of the catheter was in the tunnel track so it was easily retrieved.They removed the two catheter pieces and replaced with a new pleurx catheter.Additional information received on 04sep.1.When was this defect observed? during or before use? was not observed during case or before, catheter appeared to not to have any defects, found it on fluoro post placement.2.What was the impact to the patient? no harm, just delay in care, they opened another pleurx tray and inserted the new pleurx catheter with no issues.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None, just delay, see note above.4.Provided material# 50-7000b doesn't match our records for lot# 0001568480.Can you please check if it is a typo and provide the material number and lot number of the product associated with reported issue? item code is 50-7700.Additional information received on 12sep.1.Was the catheter broken during the catheter insertion procedure? yes, when they finished the procedure, they noticed under fluoro that the catheter had broke.2.How long has the catheter been in place ¿ patient was still on the procedure table, catheter was in place maybe 1 to 2 minutes, they were doing their post placement fluoro scan to verify placement.3.Was the place where the catheter broke internal to the body, or was the catheter broken in the external portion? internal ¿ under the skin along the tunneled path to the pleural space (not in the pleural space).4.Where is the catheter located? abdomen or chest ¿ was the chest ¿ it was immediately removed when they discovered it had broken.

• Brand Name: PLEURX PLEURAL CATHETER AND STARTER 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20268759
• Report Number: 1625685-2024-00109
• Device Sequence Number: 15282766
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520(11)240513(17)260731(10)0001568480
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• 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): 11/21/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 50-7700
• Device Lot Number: 0001568480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 64 KG