MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number HT31-BM2CO

Device Problem Bent (1059)

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

Event Date 10/17/2017

Event Type  malfunction  

Event Description

During bone biopsy needle from strl bm biopsy pr 11gx4 15gx5 kit bent.New needle had to be used.

• Brand Name: CARDINAL HEALTH
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 6995845
• MDR Text Key: 90860184
• Report Number: 6995845
• Device Sequence Number: 1
• Product Code: FSH
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2019
• Device Model Number: HT31-BM2CO
• Device Catalogue Number: HT31-BM2CO
• Device Lot Number: 397833
• Other Device ID Number: STRL BM BIOPSY PR 11GX4 15GX5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Device Age: 1 DY
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/24/2017
• 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