MAUDE Adverse Event Report: H.S. HOSPITAL SERVICE SPA TRAPSYSTEM SET; INSTRUMENT, BIOPSY

Model Number TRAPSYSTEM SET

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Event Description

During the bone marrow procedure, the (b)(6) needle bent and was unable to be used.

• Brand Name: TRAPSYSTEM SET
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): H.S. HOSPITAL SERVICE SPA; 4521-31 north dixie highway; boca raton FL 33431
• MDR Report Key: 7243593
• MDR Text Key: 99102437
• Report Number: 7243593
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 08033003347881
• UDI-Public: (01)08033003347881
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/19/2022
• Device Model Number: TRAPSYSTEM SET
• Device Catalogue Number: TRAPJ 1110
• Device Lot Number: 28929
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Device Age: 1 DY
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO