MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,IV,SURESITE SLIDE,22G X 1"

Catalog Number DYNSCS22100

Device Problem Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that the needle was dull and bent which resulted in an addittonal iv site.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Needle was dull and bent.

• Type of Device: CATHETER,IV,SURESITE SLIDE,22G X 1"
• 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: 19037816
• MDR Text Key: 339320705
• Report Number: 1417592-2024-00461
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10888277667549
• UDI-Public: 10888277667549
• 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: 04/03/2024

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: DYNSCS22100
• Device Lot Number: 27823080002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other