MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. JAMSHIDI; INSTRUMENT, BIOPSY

Model Number EJM4011

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)

Event Date 06/30/2021

Event Type  malfunction  

Event Description

Doing bmbx (bone marrow biopsy), i went to cut the bone with white cutting tool, the white piece broke and i went down and the metal straw like piece went up into my finger puncturing it.It bled.I quickly added 2 pairs of gloves 1 clean (sanitized) then 1 sterile to take the jam out of the patient safely.I then took off gloves washed my hands added an alcohol pad, regloved x 2 (1 clean & 1 sterile) opened a new sterile field and finished the procedure.I then washed my hands and went to (b)(6).I spoke with manager of (b)(6) (right away, ca's alerted her).Manufacturer response for bone marrow biopsy needle, (brand not provided) (per site reporter): will send rga for return of defective needle for evaluation and for he product we pulled.

• Brand Name: JAMSHIDI
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 12597807
• MDR Text Key: 275424967
• Report Number: 12597807
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EJM4011
• Device Catalogue Number: EJM4011
• Device Lot Number: 0001405222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1