MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; CLAVE EXTENSION SET

Catalog Number UXSN008

Device Problem Connection Problem (2900)

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

Event Date 11/13/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2022 a patient was receiving contrast for a 'cta of chest with contrast and is reporting the extension set on the iv connection loosened and cracked'.According to the customer, the patient was given 'twice the required contrast'.According to the customer, an additional iv site was placed due to the reported incident.The sample is not available to be returned for evaluation.No additional information is available at this time.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 Description

According to the customer contact, on (b)(6) 2022 a patient was receiving contrast for a 'cta of chest with contrast and is reporting the extension set on the iv 'connection loosened and cracked'.

• Type of Device: CLAVE EXTENSION SET
• 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: 15959871
• MDR Text Key: 305270300
• Report Number: 3004519921-2022-00007
• Device Sequence Number: 1
• Product Code: FPA
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UXSN008
• Device Lot Number: 2022072590
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 111 KG