MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS PLUS 8FR CATHETER; THORACENTESIS TRAY

Model Number	PIG1280TSP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported needle has detached.Verbatim: needle portion has detached.The numbing bd safety glide needles in this kit are extremely flimsy and have broken off into patients upon insertion on three different occasions.(they were easily pulled out and no patient harm done) both the 25g x 1¿ and the 22g x 1.5¿ are having the same issue and are very dangerous.Providers are requesting different kits.Staff have noticed laxity of the 25 gauge needle in the safe-t-centesis kits, to the point where the needle portion has detached from the rest of the apparatus.While there has not been patient harm, this is a safety concern as a needle might detach and be lost inside of a patient (these kits are typically used for paracentesis and thoracentesis).This issue has been noted when using these kits multiple times over the past week.
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 needle has detached.Verbatim: needle portion has detached.The numbing bd safety glide needles in this kit are extremely flimsy and have broken off into patients upon insertion on three different occasions.(they were easily pulled out and no patient harm done) both the 25g x 1¿ and the 22g x 1.5¿ are having the same issue and are very dangerous.Providers are requesting different kits.Staff have noticed laxity of the 25 gauge needle in the safe-t-centesis kits, to the point where the needle portion has detached from the rest of the apparatus.While there has not been patient harm, this is a safety concern as a needle might detach and be lost inside of a patient (these kits are typically used for paracentesis and thoracentesis).This issue has been noted when using these kits multiple times over the past week.
Additional Manufacturer Narrative
Pr 4528555 follow-up emdr for device evaluation: four photos sample were provided to our quality team for investigation.Through visual inspection, it appears as if the needle has detached near the hub portion of the needle, opposite the end near the needle bevel.The amount of force used to detach the needle or bend the needle is unknown.Therefore, the reported failure mode broken needle was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001443200 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 manufacturer here.

• Brand Name: SAFE-T-CENTESIS PLUS 8FR 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 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13671711
• Report Number: 1625685-2022-00035
• Device Sequence Number: 14778131
• Product Code: PXI
• UDI-Device Identifier: 10885403108426
• UDI-Public: (01)10885403108426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Expiration Date: 06/30/2024
• Device Model Number: PIG1280TSP
• Device Catalogue Number: PIG1280TSP
• Device Lot Number: 0001443200
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/04/2022
• 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