MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 8FR X 16CM - PIG1280T; THORACENTESIS TRAY

Model Number	PIG1280T
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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 by the distributor that the cap was loose and separated and the syringe did not eject the product into the patient.Reported issue: screw cap was loose and fell off and on to the ground.The product cap normally comes pretty tight.The third one the syringe did not eject the product into the patient.
Event or Problem Description
It was reported by the distributor that the cap was loose and separated and the syringe did not eject the product into the patient.Reported issue: screw cap was loose and fell off and on to the ground.The product cap normally comes pretty tight.The third one the syringe did not eject the product into the patient.
Additional Manufacturer Narrative
Pr (b)(4).Follow-up emdr for device evaluation: two trays containing vials and syringes of lot 0001409459 were provided to our quality team for investigation.The syringes were examined and operated as intended and the failure mode of syringe occluded was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001409459 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, a probable root cause was evaluated for this investigation as a supplier related issue.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see manufacturer here.

• Brand Name: SAFE-T-CENTESIS TRAY 8FR X 16CM - PIG1280T
• 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: 12555668
• Report Number: 1625685-2021-00066
• Device Sequence Number: 19754569
• Product Code: PXI
• UDI-Device Identifier: 10885403108402
• UDI-Public: (01)10885403108402
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: PIG1280T
• Device Catalogue Number: PIG1280T
• Device Lot Number: 0001409459
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 03/08/2022
• 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