MAUDE Adverse Event Report: CAREFUSION, INC TUBING CLAMP 8IN F/TUBING TO 7/8(22MM)OD; CLAMPS

Model Number	SU2856
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr # (b)(4).05jan2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
Material no: su2856 , batch no: d22xmr.It was reported by the customer that the instruments are bowed/have a gap that is not acceptable for cath lab.Verbatim: in regards to the patient ¿that had such high pressures it was very noticeable the clamp did not meet standards.This event is related to one patient.We were not able to occlude the cannulas thus loosing blood".No further information available.
Additional Manufacturer Narrative
Follow up mdr (b)(4).The complaint product was returned, and an evaluation was performed.The root cause of the issue could not be confirmed.The instrument was produced according to specification.The valid bd drawing of the su2856 instrument has the following inspection instructions: ¿must fully occlude tubing 22.2 o.D.With wall thickness of 3.2 on second ratchet with no leakage.¿ the returned instruments were inspected and meet this requirement.However, we asked for information on what type of pipe the user clamps with this instrument.The information received was that the user was clamping 3/8x3/32 pipe.This pipe has a diameter of 9.5 mm and a wall thickness of 2.38 mm.The su2856 instrument must be able to clamp a pipe with a diameter of 22.2 mm and a wall thickness of 3.2 mm.The returned instruments clamp the pipe of the prescribed size leak-free.The user did not use the correct type of tube clamp for the operation.The size of the pipe that can be clamped by the su2852 pipe clamp: diameter 9.5 mm and wall thickness 1.6 mm.This requirement is from the valid su2852 bd drawing.This should have been used.The product would have been manufactured and tested according to the specifications.
Event or Problem Description
Material no: su2856 batch no: d22xmr.It was reported by the customer that the instruments are bowed/have a gap that is not acceptable for cath lab.Verbatim: in regards to the patient ¿that had such high pressures it was very noticeable the clamp did not meet standards.This event is related to one patient.We were not able to occlude the cannulas thus loosing blood".No further information available.

• Brand Name: TUBING CLAMP 8IN F/TUBING TO 7/8(22MM)OD
• Common Device Name: CLAMPS
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16273590
• Report Number: 1423507-2023-00070
• Device Sequence Number: 17629596
• Product Code: HXD
• UDI-Device Identifier: 10885403064746
• UDI-Public: (01)10885403064746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023
• Report Date (Section F): 01/31/2023

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: SU2856
• Device Catalogue Number: SU2856
• Device Lot Number: D22XMR
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/31/2023