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	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needles received had metal parts bent and plastic handle detached.Metal part of the needle are in aisi 304, universally recognized metal used for medical device.Plastic part detached was the mandrel handle, we checked that glue was present so the handle was correctly assembled.We attach a technical report explaining how these problems can occur if during a biopsy "ifu" are not strictly followed.We sell more than 60.000 pcs during an year and world wide.We are receiving these kind of claims only from this hospital.We have activated our distributor in order to train operators to the correct usage of the product.We also have received back some needles supposed to have failed the aspiration of blood during the procedure.We tested the product aspiration and we have not found any problem.Please also refer to the technical report attached.Present technical report has been sent to distributor and then to final operators.[technical report (b)(4).Pdf].
Event or Problem Description
During the bone marrow procedure the jamshidi needle bent or broke and was unable to be used (3 needles used in (b)(6) 2018).

• 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: 7352372
• Report Number: 0008010312-2018-00002
• Device Sequence Number: 16160593
• Product Code: KNW
• UDI-Device Identifier: 08033003347881
• UDI-Public: 08033003347881
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: 04/20/2022
• Device Catalogue Number: TRAPJ1110
• Device Lot Number: 28929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1