MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS PLUS 6FR CATHETER; THORACENTESIS TRAY

Catalog Number	PIG1260T
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a26.Patient problem code: f24.
Event or Problem Description
It was reported by customer that they had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.Verbatim: rcc received a complaint via email.Email(s) attached.We had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.
Event or Problem Description
It was reported by customer that they had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.Verbatim: rcc received a complaint via email.Email(s) attached.We had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.Customer response on jun 28, 2024.Could you please provide a further description of the issue? the blue hub disconnected from the rest of the valve tubing construct when removing the catheter from the patient.This resulted in the catheter remaining in the patient.The catheter was then removed separately within seconds of being disconnected.However, within that short amount of time, air entered into the pleural space, which was seen as a pneumothorax on cxr post-procedure.Please specify device failure.Blue hub disconnected from threaded connection the valve tubing construct.It is a screw in/threaded connection.It most likely was not completely threaded together.What was the impact on the patient? pneumothorax.Did the patient have a pneumothorax due to a device malfunction? pneumothorax as seen on cxr.Was there any medical intervention required including diagnostics, procedures, and treatment delay? no further intervention is required.Can you please provide the material number and lot number associated with reported issue? material number: unsure where to find that information (product packaging was retained).Lot number: 0001546040.Is there a photo or sample available showing the reported issue? no photo available.How was the issue resolved? observation of pneumo.Can you please provide an exact date of event in format dd-mmm-yyyy? 05/30/2024 was date of event.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001546040 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.A quality notification has been sent to our supplier in an effort to raise awareness, and a request to investigate the issue.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 they had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.Verbatim: rcc received a complaint via email.We had an issue with safe-t-centesis 6fr catheter drainage tray, it did result in a pneumo.Customer response on (b)(6) 2024.Could you please provide a further description of the issue? the blue hub disconnected from the rest of the valve tubing construct when removing the catheter from the patient.This resulted in the catheter remaining in the patient.The catheter was then removed separately within seconds of being disconnected.However, within that short amount of time, air entered into the pleural space, which was seen as a pneumothorax on cxr post-procedure.Please specify device failure.Blue hub disconnected from threaded connection the valve tubing construct.It is a screw in/threaded connection.It most likely was not completely threaded together.What was the impact on the patient? pneumothorax.Did the patient have a pneumothorax due to a device malfunction? pneumothorax as seen on cxr.Was there any medical intervention required including diagnostics, procedures, and treatment delay? no further intervention is required.Can you please provide the material number and lot number associated with reported issue? material number: unsure where to find that information (product packaging was retained) lot number: 0001546040.Is there a photo or sample available showing the reported issue? no photo available.How was the issue resolved? observation of pneumo.Can you please provide an exact date of event in format dd-mmm-yyyy? 05/30/2024 was date of event.

• Brand Name: SAFE-T-CENTESIS PLUS 6FR CATHETER
• 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: 19614221
• Report Number: 1625685-2024-00062
• Device Sequence Number: 6306265
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(11)231211(17)260131(10)0001546040
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 09/03/2024

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: 01/31/2026
• Device Catalogue Number: PIG1260T
• Device Lot Number: 0001546040
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided; 09/03/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/01/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown