MAUDE Adverse Event Report: H.S. HOSPITAL SERVICE S.P.A. TRAPSYSTEM SET; BONE MARROW BIOPSY SET

Catalog Number	TRAPJ1110
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are fulfilling present report refering to report (b)(4).In this report the batch lot of products used are not indicated.Although we received the supposed defective product form our distributor which ensured us to be the product object of this claim.The kind of breakage we observed is due to a non-proper use of product, please look at the technical report attached.In order to avoid ant other problem we decided to better specify these aspects inside ifu section warnings.We have sent this revised ifu to distributor asking for delivery to the final user.
Event or Problem Description
Trapsystem needle handle broke off while being inserted during bone marrow biopsy.

• Brand Name: TRAPSYSTEM SET
• Common Device Name: BONE MARROW BIOPSY SET
• Manufacturer (Section D): H.S. HOSPITAL SERVICE S.P.A.; via a.vacchi 23/25; aprilia, latina 04011 ; IT 04011
• MDR Report Key: 8014147
• Report Number: 0008010312-2018-00004
• Device Sequence Number: 1434876
• Product Code: KNW
• UDI-Device Identifier: 08033003347881
• UDI-Public: 08033003347881
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K013692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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: 03/04/2022
• Device Catalogue Number: TRAPJ1110
• Device Lot Number: 28819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1