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

Catalog Number	TRAPJ1110
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Supposed defective products were not returned to manufacturer so it was not possible to make an evaluation.The whole batch lot was composed by (b)(4) pcs, sold worldwide and no such claims have been received.During the quality test performed in production nothing was wrong.Possible explanation to the problem: the handle does not detach from the needle until any metal deformation occurs.Metal cannula used is a standard aisi 304 tube o.D.3.0 mm, i.D.2.3 mm, if the medical device is used inside a very hard bone it could happen that the needle cannula can steaks inside the bone, under these conditions following the ifu, the device must be removed from the bone rotating the handle one turn on the right and one turn on the left in order to avoid any metal cannula deformation and after that the plastic handle detachment.The fact that two needles had the same problem maybe confirms that this detachment occurred in these conditions and that operator used the needle not in the right way as described in the ifu.We already informed our distributor about this problem in december 2017.(b)(4).
Event or Problem Description
As reported in mw5072812: bone marrow biopsy set.2 set broke during the procedure causing the veteran to have to be stuck three times in order to get the biopsy.The set broke at handle leaving a large needle stuck in veteran that was difficult to remove.Sa 2/2 other-equipment issue- moderate harm to patient.Bone marrow biopsy procedure to be repeated by ir.Patient underwent 3 needle attempts with one attempt resulting in handle breaking causing needle to stay in patient without handle to easily remove.Two bone marrow biopsy kits broke at point of handle leaving a large needle stuck in patient that was difficult to remove.Biopsy completed and another bone marrow procedure to be repeated by ir.

• Brand Name: TRPSYSTEM 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: 7237004
• Report Number: 0008010312-2018-00001
• Device Sequence Number: 13742784
• Product Code: KNW
• UDI-Device Identifier: 08033003347881
• UDI-Public: 08033003347881
• Combination Product (Y/N): N
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: TRAPJ1110
• Device Lot Number: 27869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1