MAUDE Adverse Event Report: CAREFUSION, INC THORA/PARA KIT, 5FR, NON-VALVED; THORACENTESIS TRAY

Model Number	OTP5000K
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that dr.Was looking at our disposable scalpel and cut his hand.Verbatim: i wasn't aware i should report that at the time.My mistake.During a product demonstration dr was looking at our disposable scalpel and cut his hand.He didn't care, and blamed himself.It was a tiny poke.Dr cut his hand with our disposable scalpel in otp5000k kit.Dr was saying how he liked the new scalpel better than the older one and proceeded to open it in the wrong direction into his hand.A very small poke enough to make him jump.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a2301.Patient problem code: (b)(4).
Event or Problem Description
It was reported by customer that dr.Was looking at our disposable scalpel and cut his hand verbatim: i wasn't aware i should report that at the time.My mistake.During a product demonstration dr was looking at our disposable scalpel and cut his hand.He didn't care, and blamed himself.It was a tiny poke.Dr cut his hand with our disposable scalpel in otp5000k kit.Dr was saying how he liked the new scalpel better than the older one and proceeded to open it in the wrong direction into his hand.A very small poke enough to make him jump.
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 0001452292 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, the most probable cause of the failure mode was user related.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.
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 0001452292 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.
Event or Problem Description
It was reported by customer that dr.Was looking at our disposable scalpel and cut his hand.Verbatim: i wasn't aware i should report that at the time.My mistake.During a product demonstration dr was looking at our disposable scalpel and cut his hand.He didn't care, and blamed himself.It was a tiny poke.Dr cut his hand with our disposable scalpel in otp5000k kit.Dr was saying how he liked the new scalpel better than the older one and proceeded to open it in the wrong direction into his hand.A very small poke enough to make him jump.

• Brand Name: THORA/PARA KIT, 5FR, NON-VALVED
• 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: 14496400
• Report Number: 1625685-2022-00060
• Device Sequence Number: 6191531
• Product Code: PXI
• UDI-Device Identifier: 10885403284755
• UDI-Public: (01)10885403284755
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 06/24/2022

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 Model Number: OTP5000K
• Device Catalogue Number: OTP5000K
• Device Lot Number: 0001452292
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 06/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/24/2022
• 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