MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; CIRCUMCISION TRAY NEWBORN NURSERY

Catalog Number	CIT6610A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to customer, the "provider noted floating object inside the syringe prior to use of injecting lidocaine for a newborn male infant.The syringe is a 1ml tuberculin safety syringe".The customer stated there was no serious injury or medical intervention and that a sample is available for evaluation.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to customer, the "provider noted floating object inside the syringe prior to use of injecting lidocaine for a newborn male infant.The syringe is a 1ml tuberculin safety syringe".

• Common Device Name: CIRCUMCISION TRAY NEWBORN NURSERY
• 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: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19204311
• Report Number: 3004122598-2024-00034
• Device Sequence Number: 15425760
• Product Code: OHG
• UDI-Device Identifier: 10653160324096
• UDI-Public: 10653160324096
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Catalogue Number: CIT6610A
• Device Lot Number: 21IBI288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown