MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; NDL,WHITACRE SPINAL,24GX4" NO INTRODUCER

Model Number PAIN8030

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 when inserting the spinal needle the physician did not have any return "csf", and upon removal of the needle with "no resistance" only "half" of the expected needle length was withdrawn from the patient.The customer reported the patient required an interventional radiology procedure in order to remove the retained needle.The customer reported an additional spinal needle was required to be inserted.The customer reported the patient was discharged home on (b)(6) 2023 with "no issues".Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, 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 customer, on (b)(6) 2023 when inserting the spinal needle the physician did not have any return "csf", and upon removal of the needle with "no resistance" only "half" of the expected needle length was withdrawn from the patient.

• Brand Name: Medline
• Type of Device: NDL,WHITACRE SPINAL,24GX4" NO INTRODUCER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16717811
• MDR Text Key: 313071150
• Report Number: 1417592-2023-00161
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 10889942474127
• UDI-Public: 10889942474127
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PAIN8030
• Device Catalogue Number: PAIN8030
• Device Lot Number: 22E385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other