MAUDE Adverse Event Report: TELEFLEX MEDICAL ONCONTROL COAXIAL BIOPSY TRAY 10/12 GA; BIOPSY NEEDLE KIT

Catalog Number 9463-VC-006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the tip of biopsy needle broke.The biopsy was on a right tibial lesion.The needle breakage occurred during the positioning phase of the procedure.The tip of the needle was retrieved, they were able to complete the bone biopsy.There was no harm to the patient.

Event Description

It was reported that the tip of biopsy needle broke.The biopsy was on a right tibial lesion.The needle breakage occurred during the positioning phase of the procedure.The tip of the needle was retrieved, they were able to complete the bone biopsy.There was no harm to the patient.

Manufacturer Narrative

Qn#(b)(4).The dhr file is not available for review in the us.Received one (1) biopsy cannula, 10/12ga.From oncontrol set, 9463-vc-006, oncontrol coaxial biopsy tray 10/12 ga, for investigation.The cannula was visually inspected upon receipt for any signs of abuse/misuse/damage.The cannula tip was clearly damaged.The cannula tip was placed under magnification for a closer examination of the physical condition.It appears the tip was completely twisted or sheared off.There is also an obvious bulge in the cannula tip just behind the cannula orifice indicating the cannula metal was stressing prior to breakage.The damage has been confirmed.A section of the ifu will be referenced as part of this investigation report.The ifu states, "locate insertion site with needle set on the periosteum.Note depth marking.Squeeze trigger to penetrate cortex to medullary space.Do not apply excessive force to driver/needle set." the certificate of compliance certifies that the referenced product was manufactured, including reconciliation of printed label quantities, using agreed upon specifications and in accordance with fda and iso quality system requirements.Sterile-labeled products were processed for sterility in a validated cycle using 100% ethylene oxide gas.The complaint has been confirmed via visual inspection.A definitive root cause cannot be assigned.No corrective/preventative actions will be assigned.The complaint has been confirmed via visual inspection.The lack of detailed information and more photos prevents a definitive root cause from being assigned.No further action required.

• Brand Name: ONCONTROL COAXIAL BIOPSY TRAY 10/12 GA
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8896726
• MDR Text Key: 154413385
• Report Number: 3011137372-2019-00244
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K113872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Catalogue Number: 9463-VC-006
• Device Lot Number: 31710359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention