MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES T. FUKUSHIMA TAPERED TEARDROP SUCTION TUBES

Catalog Number	R9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that both tip ends of the ruggles t.Fukushima tapered teardrop suction tubes (r9003) broke intra-operatively, during neurosurgery.Broken parts reportedly fell into the surgical site and the remnants were fortunately retrieved under microscope vision.All broken parts were recovered.The procedure was completed using alternative suction tubes.The patient was in stable condition post-procedure.No patient injury of surgical delay was reported.
Additional Manufacturer Narrative
The ruggles t.Fukushima tapered teardrop suction tubes was not returned to the manufacturer; therefore, an evaluation of the actual device could not be performed.A review of the device history record was performed and no abnormalities related to the reported issue were identified.The image provided by the customer appears to be an intact product in its packaging and not the complaint product.The customer indicated a product purchase date of apr-2020.A definitive root cause could not be determined.The issue of a broken tip may be the result of wear or rough handling over three years of use.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h10, h11.Corrected fields: b2, h6 (type of investigation 1).
Event or Problem Description
N/a.

• Brand Name: RUGGLES T. FUKUSHIMA TAPERED TEARDROP SUCTION TUBES
• Common Device Name: SUCTION TUBE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17726897
• Report Number: 3014334038-2023-00147
• Device Sequence Number: 6440611
• Product Code: JOL
• UDI-Device Identifier: 10381780131946
• UDI-Public: 10381780131946
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Catalogue Number: R9003
• Device Lot Number: AX1907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/17/2023
• Date Device Manufactured: 07/31/2019
• 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 Sex: Unknown