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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: H.S. HOSPITAL SERVICE S.P.A. TRAPSYSTEM SET; BONE MARROW BIOPSY SET
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H.S. HOSPITAL SERVICE S.P.A. TRAPSYSTEM SET; BONE MARROW BIOPSY SET Back to Search Results
Catalog Number TRAPJ1110
Medical Device Problem Code Pressure Problem (3012)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Three (3) needles have been tested.Two (2) needles resulted defective during the aspiration.Cause of the problem is probably a lack of glue during assembly.We replaced the defective products to the hospital.
 
Event or Problem Description
During the bone marrow procedure the jamshidi needle had a problem during the aspiration (lack of depression, 3 needles were defective).
 
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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 Key7453844
Report Number0008010312-2018-00003
Device Sequence Number1510387
Product Code KNW
UDI-Device Identifier08033003347881
UDI-Public08033003347881
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K013692
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date (Section B) 03/06/2018
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 Date07/26/2022
Device Catalogue NumberTRAPJ1110
Device Lot Number29708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/05/2018
Initial Report FDA Received Date04/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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