MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS THORACENTESIS/PARACENTESIS; THORACENTESIS TRAY

Model Number	TPT1000SP
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that the needles broke.Verbatim: srg ¿ vh - tpt1000sp ¿ lot: 0001449441 - during the case the needle broke off.This afternoon dr.(b)(6) was preforming a thoracentesis and during the case the needle broke off.He then proceeded to get another thoracentesis kit, in which the needle in that kit bent as he was performing the procedure.I'm unsure if it is a specific lot of these carefusion thora/para kits, but, i wanted to bring it to everyone's attention.Was the broken needle and the bent needle observed before use or during the use on patient? we used two kits.With the first kit the joint where the needle and the syringe meet felt flimsy which was unusually.I strongly suspect the needle was bent prior to use but did not directly observe.With the second kit, again the catheter hub was not flush and this time i did observe that the needle was bent before use, but was still patent and otherwise function.What was the procedure that was being performed? throacentesis.How was item piece retrieved from patient/procedure? the needle broke after we had removed it fully from the patient.There was pleural fluid leaking from the point where the needle meets the syringe but not going into the syringe.Thus we aborted the procedure.With very light manipulation, once all equipment was removed from the patient, to investigate the issue, the needle broke off.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? there was no need.What was the impact to the patient? procedure completion was delayed as we had to obtain a second kit.Thus, also two attempts were needed to successfully complete the procedure.There was no harm to the patient.Was the procedure completed as planned? because the needle from the second kit was bent we had to modify our technique so to avoid putting pressure on the bent area to avoid a repeat of the complication from the initial attempt.
Event or Problem Description
It was reported that the needles broke.Verbatim: srg ¿ vh - tpt1000sp ¿ lot: 0001449441 - during the case the needle broke off.This afternoon dr.(b)(6) was preforming a thoracentesis and during the case the needle broke off.He then proceeded to get another thoracentesis kit, in which the needle in that kit bent as he was performing the procedure.I'm unsure if it is a specific lot of these carefusion thora/para kits, but, i wanted to bring it to everyone's attention.Was the broken needle and the bent needle observed before use or during the use on patient? we used two kits.With the first kit the joint where the needle and the syringe meet felt flimsy which was unusually.I strongly suspect the needle was bent prior to use but did not directly observe.With the second kit, again the catheter hub was not flush and this time i did observe that the needle was bent before use, but was still patent and otherwise function.What was the procedure that was being performed? throacentesis.How was item piece retrieved from patient/procedure? the needle broke after we had removed it fully from the patient.There was pleural fluid leaking from the point where the needle meets the syringe but not going into the syringe.Thus we aborted the procedure.With very light manipulation, once all equipment was removed from the patient, to investigate the issue, the needle broke off.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? there was no need.What was the impact to the patient? procedure completion was delayed as we had to obtain a second kit.Thus, also two attempts were needed to successfully complete the procedure.There was no harm to the patient.Was the procedure completed as planned? because the needle from the second kit was bent we had to modify our technique so to avoid putting pressure on the bent area to avoid a repeat of the complication from the initial attempt.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: eight photos were provided to our quality team for investigation.Through visual inspection, it was observed that the bent and broken needle ; therefore, the reported failure could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001449441 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.H3 other text : see manufacture narration.

• Brand Name: SAFE-T PLUS THORACENTESIS/PARACENTESIS
• 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: 14712655
• Report Number: 1625685-2022-00065
• Device Sequence Number: 2265048
• Product Code: PXI
• UDI-Device Identifier: 10885403108433
• UDI-Public: (01)10885403108433
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: Health Professional
• Device Model Number: TPT1000SP
• Device Catalogue Number: TPT1000SP
• Device Lot Number: 0001449441
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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