MAUDE Adverse Event Report: CAREFUSION, INC THORA/PARA TRAY, 5FR, NON-VALVED; THORACENTESIS TRAY

Model Number	OTP5000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A carefusion catheter from a thora-para 5 fr non-valved catheter drainage tray fell apart during a procedure today.The patient was affected.Lot #0001485831.See photo below.Additional information received 14-mar-2023 please confirm the material number.Otp5000 can you describe and provide more information on how the tray fell apart? catheter fell apart ¿ introducer needle disassembled from vent plug.How was the patient impacted? hub separation from catheter caused chest to be exposed to air causing small pneumothorax.Was there any need for medical treatment or intervention? syringe was used to aspirate air, postprocedural chest x-ray performed noting small hydropneumothorax.Next day follow-up.No further action required.Are there any patient identifiers? not on the product, able to provide if necessary.Do you have the product to send back for evaluation? yes.
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: f22.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo and one sample were provided to our quality team for investigation.Through visual inspection, it was observed that the hub detached from the catheter; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001485831 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, the probable root cause of the issue determination will be provided through the supplier corrective action request.Scar was issued to the supplier.Manufacturing personnel have been notified of this incident and awareness training was provided.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.
Event or Problem Description
A carefusion catheter from a thora-para 5 fr non-valved catheter drainage tray fell apart during a procedure today.The patient was affected.Lot #0001485831.Additional information received 14-mar-2023 ¿ please confirm the material number.Otp5000 ¿ can you describe and provide more information on how the tray fell apart? catheter fell apart ¿ introducer needle disassembled from vent plug ¿ how was the patient impacted? hub separation from catheter caused chest to be exposed to air causing small pneumothorax ¿ was there any need for medical treatment or intervention? syringe was used to aspirate air, postprocedural chest x-ray performed noting small hydropneumothorax.Next day follow-up.No further action required.¿ are there any patient identifiers? not on the product, able to provide if necessary.¿ do you have the product to send back for evaluation? yes 14-mar-2023 ¿ please confirm the material number.Otp5000 ¿ can you describe and proivde more information on how the tray fell apart? catheter fell apart ¿ introducer needle disassembled from vent plug ¿ how was the patient impacted? hub separation from catheter caused chest to be exposed to air causing small pneumothorax ¿ was there any need for medical treatment or intervention? syringe was used to aspirate air, postprocedural chest x-ray performed noting small hydropneumothorax.Next day follow-up.No further action required.¿ are there any patient identifiers? not on the product, able to provide if necessary.¿ do you have the product to send back for evaluation? yes additional information received 03-apr-2023 ¿ was the catheter inserted in the patient when the piece broke? yes ¿ was there any medical intervention? can we get more details related to how the patient was impacted.¿syringe was used to aspirate air, postprocedural chest x-ray performed noting small hydropneumothorax.Next day follow-up.No further action required.¿ the patient was impacted by the formation of a hydropneumothorax as a result of the catheter breaking during the procedure.¿ was the procedure successfully completed? yes, the procedure was completed with 0.675 liters.Patient returned next day for follow-up and repeat thoracentesis to draw off an additional.9 liters.¿ we would like to have any patient identifiers that are available.What identifiers are there? patient is 71 yr old female and is a repeat thoacentesis patient (over 65 exams completed) and coming in almost 3 times a week.She is very sensitive on that side at this point which makes her a difficult patient but the radiologist have not had issues in obtaining fluid.

• Brand Name: THORA/PARA TRAY, 5FR, NON-VALVED
• Common Device Name: THORACENTESIS TRAY
• 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: 16587886
• Report Number: 1625685-2023-00032
• Device Sequence Number: 5729187
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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 Expiration Date: 07/31/2024
• Device Model Number: OTP5000
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001485831
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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 Age: 71 YR
• Patient Sex: Female