MAUDE Adverse Event Report: CAREFUSION, INC THORA/PARA TRAY, 5FR- NON-VALVED - OTP5000; 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	12/27/2021
Type of Reportable Event	Malfunction
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 catheter broke when using on patient.There was a retained yeuh catheter reported during a bedside paracentesis procedure.Storeroom, purchasing and risk management were notified.The affected supply was retrieved cross campus from the pyxis and storeroom stock locations.The fda and manufacturer were alerted to the event as well.Unfortunately, a kit with the same lot# was stored on a unit¿s pulmonary cart and used on a different patient.This resulted in a near miss event in which the yeuh catheter broke and had the potential for retention.Fortunately, there was no harm to the patient during this second event.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: ten samples 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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001437013 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 manufacturer here.
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 number 0001437013 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.
Event or Problem Description
It was reported that catheter broke when using on patient.Verbatim: srg there was a retained yeuh catheter reported during a bedside paracentesis procedure.Storeroom, purchasing and risk management were notified.The affected supply was retrieved cross campus from the pyxis and storeroom stock locations.The fda and manufacturer were alerted to the event as well.Unfortunately, a kit with the same lot# was stored on a unit¿s pulmonary cart and used on a different patient.This resulted in a near miss event in which the yeuh catheter broke and had the potential for retention.Fortunately, there was no harm to the patient during this second event.
Event or Problem Description
It was reported that catheter broke when using on patient.Verbatim: srg.There was a retained yeuh catheter reported during a bedside paracentesis procedure.Storeroom, purchasing and risk management were notified.The affected supply was retrieved cross campus from the pyxis and storeroom stock locations.The fda and manufacturer were alerted to the event as well.Unfortunately, a kit with the same lot# was stored on a unit¿s pulmonary cart and used on a different patient.This resulted in a near miss event in which the yeuh catheter broke and had the potential for retention.Fortunately, there was no harm to the patient during this second event.

• Brand Name: THORA/PARA TRAY, 5FR- NON-VALVED - OTP5000
• 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: 13236215
• Report Number: 1625685-2022-00004
• Device Sequence Number: 4554667
• 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,Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 04/15/2022; 06/14/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/15/2022; 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