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	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that piece broke apart.Email verbatim: here are the pictures of the product information and the piece that broke apart.Was the catheter broke during the procedure or before the procedure? the tube broke away from the hub when it was being removed from the patient¿s chest.No defect was noticed prior to use.Is there a photo or sample available showing the reported issue for the evaluation? what was the impact to the patient? how was the issue resolved? (b)(6) 2022: the patient had a small pneumothorax.It did resolve and we did not have to put a chest tube in.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Material # otp5000.Batch # 0001458459.It was reported by customer that piece broke apart.Email verbatim: here are the pictures of the product information and the piece that broke apart.Was the catheter broke during the procedure or before the procedure? the tube broke away from the hub when it was being removed from the patient¿s chest.No defect was noticed prior to use.Is there a photo or sample available showing the reported issue for the evaluation? what was the impact to the patient? how was the issue resolved? on 06may2022: the patient had a small pneumothorax.It did resolve and we did not have to put a chest tube in.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.During visual inspection, separated catheter tube and a hub was observed.The specification, for the tube and hub to separate at about 3 pounds of force, indicates the item allowed the separation and was working as intended.The separation was confirmed.This is not considered as a failure.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001458459 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: 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: 14373353
• Report Number: 1625685-2022-00051
• Device Sequence Number: 11274280
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 12/31/2024
• Device Model Number: OTP5000
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001458459
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/19/2022
• 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