MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 6FR X 16CM; THORACENTESIS TRAY

Catalog Number	PIG1260T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0504, patient problem code: f26.
Event or Problem Description
It was reported by customer that the bxt pig1260t that was defective.The hub where the needle comes out was leaking and sucks air (supposed to be a closed valve).Verbatim: rcc received a complaint via email.Email(s) attached.Item: (b)(4), quantity affected: (b)(4) ea, serial/lot number: (b)(6).Reported issue per customer: 3/19/2024 xxxxxx reports that they had 1 ea bxt pig1260t that was defective.The hub where the needle comes out was leaking and sucks air (supposed to be a closed valve).Lot #0001548326, exp date 2026-01-31.Customer has sample to send in.Injuries or adverse event: no.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one catheter and veress needle was provided to our quality team for investigation.Through visual inspection, we were unable to recreate the failure, fluid was drawn through the veress/catheter assembly, and no leaking was observed; therefore, the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001548326 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 by customer that the bxtpig1260t that was defective.The hub where the needle comes out was leaking and sucks air (supposed to be a closed valve).Verbatim: rcc received a complaint via email.Email(s) attached.3/19/2024 xxxxxn reports that they had 1 ea bxtpig1260t.Reported issue per customer: 3/19/2024 xxxxxx reports that they had 1 ea bxtpig1260t that was defective.The hub where the needle comes out was leaking and sucks air (supposed to be a closed valve).Lot #0001548326, exp date 2026-01-31.Customer has sample to send in.Injuries or adverse event: no.

• Brand Name: SAFE-T-CENTESIS TRAY 6FR X 16CM
• 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: 19080239
• Report Number: 1625685-2024-00033
• Device Sequence Number: 6271862
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/21/2024

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: 01/31/2026
• Device Catalogue Number: PIG1260T
• Device Lot Number: 0001548326
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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