MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS NEEDLE SET KIT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of detached intraosseous needle stylet magnets was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting an intraosseous needle.The stylet magnet was in place on the depicted device.Also visible were two loose stylet magnets.The magnets appeared to have become detached from two different stylet assemblies.While detached magnets were observed in the submitted photograph, inspection of the photograph was insufficient to identify the cause.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include insufficient adhesive application and insufficient adhesive curing during device assembly.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the customer that the magnet is from the needle not staying inside the drill when they go to remove them.Add info rcvd 06/22/2022: : customer has stated the magnet from io needle detaches from the needle and stays in the driver.They don¿t realize this is an issue until they go to connect another one the next time it is needed and it won¿t stay in place.They then have tapped the driver on the table and the needles from previous uses fall out.12/21/2021 - two devices were returned for evaluation.This report addresses the second device.

• Brand Name: BD INTRAOSSEOUS NEEDLE SET KIT
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16036323
• MDR Text Key: 308161043
• Report Number: 3006260740-2022-05816
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: D015451NK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1397-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other