MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; NEEDLE, QUINCKE, 22GX7"

Model Number PAIN8024

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 "the doctor put the needle into the patient's spine and when he went to pull off the stylet the needle broke off into the patient." per the facility the doctor used a hemostat to remove the stylet and the rest of the procedure was completed as normal.Patient is reported to be doing well.The device is available but has not been returned for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2022 "the doctor put the needle into the patient's spine and when he went to pull off the stylet the needle broke off into the patient.".

• Brand Name: Medline
• Type of Device: NEEDLE, QUINCKE, 22GX7"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16060426
• MDR Text Key: 306255594
• Report Number: 1417592-2022-00246
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PAIN8024
• Device Catalogue Number: PAIN8024
• Device Lot Number: 21L597
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 145 KG