MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS THORA/PARA, 5 FR; NEEDLE, CATHETER

Model Number	TPT1005SP
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/30/2020
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.
Event or Problem Description
Material no.: tpt1005sp, batch no.: 0001381128.It was reported that when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3 way housing.Per attached form: per the physician: "after puncture, when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3way housing.This allowed air to travel quickly into the pleural space.I was not able to cover it with my finger due to its irregular shape, and it took me a moment to turn the 3way to closed position." customer response: please confirm whether or not there was any patient impact.Patient developed a moderate pneumothorax.Do you have photos showing the reported issue? pictures attached.What procedure was being done when the reported issue occurred? thoracentesis.Please use the attached pre-paid shipping label to return instrument for investigation.The device was not saved.
Additional Manufacturer Narrative
Revising from product problem to adverse event.
Event or Problem Description
Material no.: tpt1005sp, batch no.: 0001381128.It was reported that when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3 way housing.Per attached form: per the physician: "after puncture, when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3way housing.This allowed air to travel quickly into the pleural space.I was not able to cover it with my finger due to its irregular shape, and it took me a moment to turn the 3way to closed position." customer response: please confirm whether or not there was any patient impact.Patient developed a moderate pneumothorax.Do you have photos showing the reported issue? pictures attached.What procedure was being done when the reported issue occurred? thoracentesis.Please use the attached pre-paid shipping label to return instrument for investigation.The device was not saved.
Additional Manufacturer Narrative
Dhr review did not identify any issues during the manufacture of tpt1005sp lot 0001381128, the investigation was able to confirm the reported failure mode ¿disconnected¿ utilizing the provided photographs.However, no sample was provided for evaluation and the photographs provided did not provide enough clarity to determine where and how the device broke.As a result, a probable root cause could not be determined.Since no probable root cause could be identified, no actions will be implemented at this time.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
Event or Problem Description
Material no.: tpt1005sp; batch no.: 0001381128.It was reported that when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3 way housing.Per attached form: per the physician: "after puncture, when removing the metal stylet, the ball valve and membrane mechanism pulled out of the 3way housing.This allowed air to travel quickly into the pleural space.I was not able to cover it with my finger due to its irregular shape, and it took me a moment to turn the 3way to closed position." customer response: please confirm whether or not there was any patient impact.Patient developed a moderate pneumothorax.Do you have photos showing the reported issue? pictures attached.What procedure was being done when the reported issue occurred? thoracentesis.Please use the attached pre-paid shipping label to return instrument for investigation.The device was not saved.

• Brand Name: SAFE-T PLUS THORA/PARA, 5 FR
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11119794
• Report Number: 1625685-2020-00099
• Device Sequence Number: 14465776
• Product Code: PXI
• UDI-Device Identifier: 10885403220869
• UDI-Public: (01)10885403220869
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2021

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: 12/31/2021
• Device Model Number: TPT1005SP
• Device Catalogue Number: TPT1005SP
• Device Lot Number: 0001381128
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 05/21/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/25/2021; 05/21/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention