MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; 25G NEEDLE IN LAP CHOLE CDS-LF

Model Number	CDS985291B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the needle detached and "was lost" in the patient "upon injection." the needle was successfully retrieved "without complications to the patient." despite multiple good faith attempts, the reporting facility was unable or unwilling to provide any additional information related to the incident.No sample has been returned for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to retrieve the needle from the patient, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the needle detached and "was lost" in the patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: 25G NEEDLE IN LAP CHOLE CDS-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12016258
• Report Number: 1423395-2021-00028
• Device Sequence Number: 4764013
• Product Code: FDE
• UDI-Device Identifier: 10889942279760
• UDI-Public: 10889942279760
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: CDS985291B
• Device Catalogue Number: CDS985291B
• Device Lot Number: 21CBM956
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention