MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; DBD-KIT,ADMIT,BABY,PROVIDENCE RGNL

Model Number DYK1154181B1

Device Problem Connection Problem (2900)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a needle detached from a luer slip syringe component at the needle-syringe hub as the needle was being removed from a patient.No serious injury or medical intervention was originally reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.No photo for review or sample for evaluation was provided.The dyk1154181b1 pack was identified to have incorrectly contained a luer slip syringe when it should have had a luer lock syringe.The root cause was determined to be an issue related to a component substitution within the pack.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6)2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a needle detached from a luer slip syringe component.

• Type of Device: DBD-KIT,ADMIT,BABY,PROVIDENCE RGNL
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center no.106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18881406
• MDR Text Key: 337406783
• Report Number: 3004122598-2024-00023
• Device Sequence Number: 1
• Product Code: OKV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

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 Model Number: DYK1154181B1
• Device Lot Number: 21KBC724
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other