MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS Medline; IV EXT SET, 6.5", 0.7ML, NONBOND NF VALV

Model Number DYNDTC5077

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility during a ct study, "the ct tech injected saline in the right ante-cubital and then proceeded with contrast, upon reviewing the image the contrast was not visible, and when pulling the patient out of the ct table the patient's upper body was wet and saline lock was ruptured".Per the facility a second iv site was required and the study was considered "suboptimal".A sample was returned for evaluation, however, a definitive root cause could not be determined at this time.No additional information is available at this time.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

According to the facility during a ct study, "the ct tech injected saline in the right ante-cubital and then proceeded with contrast, upon reviewing the image the contrast was not visible, and when pulling the patient out of the ct table the patient's upper body was wet and saline lock was ruptured".

• Brand Name: Medline
• Type of Device: IV EXT SET, 6.5", 0.7ML, NONBOND NF VALV
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16273061
• MDR Text Key: 308487498
• Report Number: 3004519921-2023-00002
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10080196141883
• UDI-Public: 10080196141883
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNDTC5077
• Device Catalogue Number: DYNDTC5077
• Device Lot Number: 22066232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Date Manufacturer Received: 01/04/2023
• 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