MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER, IV, SURESITE AUTO, 20G X 1.00

Catalog Number DYNA20100Z

Device Problem Connection Problem (2900)

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

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

T was reported by the customer contact that "after placing iv, staff noted leaking from insertion site.Iv discontinued and staff inspected cath/hub, saline flushed through iv and staff able to see leaking from where the clear sheath meets the pink hub".It was reported that due to this, an additional iv was placed.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Leaking from iv insertion site.

• Type of Device: CATHETER, IV, SURESITE AUTO, 20G X 1.00
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19013259
• MDR Text Key: 339035170
• Report Number: 1417592-2024-00452
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 01019348914010
• UDI-Public: 1019348914010
• 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: 04/01/2024

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
• Device Catalogue Number: DYNA20100Z
• Device Lot Number: 27823090004
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other