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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheters are defective.Verbatim: here are the details around the otp5000 product i retrieved from both campuses: 8 each - john muir concord campus, lot# 0001441008.2 each - john muir concord campus, lot# 0001437013.Per sales rep not all products broke during use.Products were defective prior to use, however sales rep was unable to give specifics.Attached is the video sent to me from a physician who went to use the otp5000 thoracentesis catheter.As you can see he is able to disconnect the blue catheter from the hub quite easily.
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
It was reported that catheters are defective.Here are the details around the otp5000 product i retrieved from both campuses: 8 each - john muir concord campus lot# 0001441008.2 each - john muir concord campus lot# 0001437013.Per sales rep not all products broke during use.Products were defective prior to use, however sales rep was unable to give specifics.Attached is the video sent to me from a physician who went to use the otp5000 thoracentesis catheter.As you can see he is able to disconnect the blue catheter from the hub quite easily.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: ten samples and one video were provided to our quality team for investigation.Upon visual inspection of these trays no issues were noted therefore, the reported failure mode was not confirmed.The video confirms the product drawing statement that the catheter must meet force at break requirements.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 0001441008 & 0001437013 were 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.

• 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: 14516709
• Report Number: 1625685-2022-00062
• Device Sequence Number: 12394704
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/14/2022

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 Expiration Date: 10/31/2022
• Device Model Number: OTP5000
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001437013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/14/2022
• 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