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

Catalog Number	PIG1260T
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a050402 patient problem code: f23.
Event or Problem Description
It was reported by customer that valve (needle entry point) leaking air during thoracentesis procedure.Caused small pneumothorax, but they were able to remove air with vacuum bottle during pleural fluid drainage.They determined it was the valve area by putting their finger over the hub and air stopped.Verbatim: pig1260t - valve (needle entry point) leaking air during thoracentesis procedure.Caused small pneumothorax, but they were able to remove air with vacuum bottle during pleural fluid drainage.They determined it was the valve area by putting their finger over the hub and air stopped.No harm to patient, but did have small amount of air left, but after a scan of the lung space, the physician determined it would resolve on its own.Lot#0001569882 customer response on (b)(6) 2024 this patient was in our department for a right thoracentesis.The centesis catheter was inserted by our pa.After the catheter was inserted, i noticed bubbles mixing with fluid in the drainage tubing and could hear a slight hissing sound coming from the catheter.Upon investigation, i determined the sound was coming from the valve and the noise stopped once i placed my finger over the valve.A 1-liter pre-evacuated vacuum container was used to drain 600cc of frothy fluid and air.A post-procedure chest x-ray reveled a small right pneumothorax, which did not require intervention.As far as i could tell, there was no visible damage to the device.
Additional Manufacturer Narrative
H10: (b)(4).Follow-up emdr for device evaluation- one veress/catheter assembly sample was received by our quality team for investigation.We were unable to recreate a failure.The supplier has been notified, and the sample will be sent to the supplier for further evaluation; 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 0001569882 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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that valve (needle entry point) leaking air during thoracentesis procedure.Caused small pneumothorax, but they were able to remove air with vacuum bottle during pleural fluid drainage.They determined it was the valve area by putting their finger over the hub and air stopped.Verbatim: pig1260t - valve (needle entry point) leaking air during thoracentesis procedure.Caused small pneumothorax, but they were able to remove air with vacuum bottle during pleural fluid drainage.They determined it was the valve area by putting their finger over the hub and air stopped.No harm to patient, but did have small amount of air left, but after a scan of the lung space, the physician determined it would resolve on its own.Lot#0001569882.Customer response on aug 23, 2024.This patient was in our department for a right thoracentesis.The centesis catheter was inserted by our pa.After the catheter was inserted, i noticed bubbles mixing with fluid in the drainage tubing and could hear a slight hissing sound coming from the catheter.Upon investigation, i determined the sound was coming from the valve and the noise stopped once i placed my finger over the valve.A 1-liter pre-evacuated vacuum container was used to drain 600cc of frothy fluid and air.A post-procedure chest x-ray reveled a small right pneumothorax, which did not require intervention.As far as i could tell, there was no visible damage to the device.

• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20108372
• Report Number: 1625685-2024-00099
• Device Sequence Number: 12678711
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(11)240523(17)260331(10)0001569882
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 12/12/2024

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: 03/31/2026
• Device Catalogue Number: PIG1260T
• Device Lot Number: 0001569882
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White