MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY QUICK CONNECT TUBING SET (5 PACK)

Catalog Number	C7300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the cusa clarity quick connect tubing set (5 pack) (c7300) tubing broke off on the field during use.A new tubing was opened to swap out and it broke in the same spot while the scrub tech was setting it up.They had to open a third tubing which worked.The device was in contact with the patient; however, no patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
The cusa clarity quick connect tubing set (c7300) was not returned for evaluation and no photos were provided to evidence the reported condition; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h10.(b)(4) cusa clarity quick connect tubing set (5 pack) ((b)(6)) was returned for evaluation: failure analysis - both devices were visually inspected, and it was observed that the ¿luer to barb fitting¿ was broken on each of the (b)(6) units.On both fittings, a ¿flat¿ section was noticed at the breakage area at about 4.5 mm from the base and an uneven section with a torn/forced appearance.However, at the moment, it cannot be determined if the breakage is due to improper handling of the device in the field or a component manufacturing defect.Root cause - the complaint is considered confirmed for the reported condition, ¿broke off on the end that fits into the handpiece.¿ the most probable root cause could be related to an undetected component manufacturing defect or product handling in the field.However, no adverse trend was identified related to the reported condition; therefore, no action is deemed necessary at this moment.

• Brand Name: CUSA CLARITY QUICK CONNECT TUBING SET (5 PACK)
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17702493
• Report Number: 3006697299-2023-00095
• Device Sequence Number: 6719464
• Product Code: LFL
• UDI-Device Identifier: 10381780126287
• UDI-Public: 10381780126287
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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: 04/30/2026
• Device Catalogue Number: C7300
• Device Lot Number: 7230696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 10/06/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/21/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female