MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC MCKESSON; MCKESSON SLIDE STYLE SAFETY IV CATHETER 22G X 1"

Model Number	200-IVS221
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We had a patient who we were starting an iv on in the pre-op setting getting a routine iv.During the iv start the rn noted blood flow leakage when the catheter was advanced into the vein.She then withdrew the needle and clear safety housing from the hub.This is when it was noted that the plastic tip was not present on the blue hub going into the patients skin.The physician's assessed the hand and did state that they could palpate the plastic catheter under the patient's skin and felt it was in the vein.Pressure dressing was placed above the site and the area was marked.The patient was sent to flower hospital for removal of foreign object.Patient had an area where the catheter felt to be present right by insertion site of iv start and pressure dressing was applied above site to prevent migration.It was also marked.It was confirmed via ultrasound at flower hospital that catheter is present in patients left hand and plastic surgery has been consulted for removal.
Event or Problem Description
We had a patient who we were starting an iv on in the pre-op setting getting a routine iv.During the iv start the rn noted blood flow leakage when the catheter was advanced into the vein.She then withdrew the needle and clear safety housing from the hub.This is when it was noted that the plastic tip was not present on the blue hub going into the patients skin.The physician's assessed the hand and did state that they could palpate the plastic catheter under the patient's skin and felt it was in the vein.Pressure dressing was placed above the site and the area was marked.The patient was sent to flower hospital for removal of foreign object.Patient had an area where the catheter felt to be present right by insertion site of iv start and pressure dressing was applied above site to prevent migration.It was also marked.It was confirmed via ultrasound at flower hospital that catheter is present in patients left hand and plastic surgery has been consulted for removal.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON SLIDE STYLE SAFETY IV CATHETER 22G X 1"
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby court; suite 100; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv; udyog vihar sector 18; haryana, gurugram 12201-5 ; IN 122015
• MDR Report Key: 19607268
• Report Number: 3003674698-2024-00771
• Device Sequence Number: 12352261
• Product Code: FOZ
• UDI-Device Identifier: 20612479267552
• UDI-Public: 20612479267552
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 200-IVS221
• Device Catalogue Number: 200-IVS221
• Device Lot Number: 99818
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown