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

Catalog Number	DYNSCA20100
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the customer that the intravenous catheters are dull and the nurses, "had to re-stick the patient." per customer, "needles are dull to the point that the nurse had to use extra force and patients are reporting unnecessary pain and discomfort." per customer, "nurses have had to re-stick the patient due to the vein blowing." no additional details are available related to the customer reported issue.The customer contact was unable or unwilling to provide further incident details to the manufacturer.The actual sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and 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 or Problem Description
It was reported by the customer that the intravenous catheters are dull and the nurses are "having to re-stick the patient.".
Additional Manufacturer Narrative
It was reported by the customer that the intravenous catheters are dull and the nurses, "had to re-stick the patient." per customer, "needles are dull to the point that the nurse had to use extra force and patients are reporting unnecessary pain and discomfort." per customer, "nurses have had to re-stick the patient due to the vein blowing." no additional details are available related to the customer reported issue.The customer contact was unable or unwilling to provide further incident details to the manufacturer.The actual sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and 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 or Problem Description
It was reported by the customer that the intravenous catheters are dull and the nurses are "having to re-stick the patient.".

• Common Device Name: CATHETER, IV, SURESITE AUTO, 20G X 1.00
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13545866
• Report Number: 1417592-2022-00015
• Device Sequence Number: 12066040
• Product Code: FOZ
• UDI-Device Identifier: 10888277667440
• UDI-Public: 10888277667440
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNSCA20100
• Device Lot Number: 27821080002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown