MAUDE Adverse Event Report: RANFAC CORP. RTN-114-T, F/G, STERILE; BONE MARROW CANNULA - TWEEZER

Model Number 74213-01M

Device Problems Break (1069); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device returned for review.The cannula trap handle has broken off as well as the handle on the needle.Since the distal portion of the cannula was not returned, a full review could not be done on the device.The device must have experienced excessive torgue or tensile during use.The dhr has been reviewed.No other complaints have been logged in over 3 years for this type of malfunction.Torque and tensile data has been reviewed for the molding of the handle to the cannula for this specific lot.Tensile is measured in lbf.Torque is measured in in-lbs.The specs are 25 lbf for tensile and 10 in-lbs for torque.All tested samples passed the requirements.(b)(6).

Event Description

Per complaint from mermaid."needle broke off inside the patient.The handle stripped and was then useless.3 cm of the needle is left inside the body." "by stripped they mean that the needle (handle) came loose from the device (cannula) and also the customer inform that the needle weakened and broke as they were trying to remove it from the patient.".

• Brand Name: RTN-114-T, F/G, STERILE
• Type of Device: BONE MARROW CANNULA - TWEEZER
• Manufacturer (Section D): RANFAC CORP.; 30 doherty ave.; avon MA 02322
• Manufacturer (Section G): RANFAC CORP.; 30 doherty ave.; avon MA 02322
• Manufacturer Contact: eric kreuz ; 30 doherty ave.; avon, MA 02322 ; 5085884400
• MDR Report Key: 9006521
• MDR Text Key: 219185482
• Report Number: 1211566-2019-00005
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• PMA/PMN Number: K983187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2019,09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Model Number: 74213-01M
• Device Catalogue Number: 74213-01M
• Device Lot Number: 41062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1211566-2019-00005
• Patient Sequence Number: 1