MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS MEDLINE; DBD-TRIPLE LUMEN CVC 20CM BUNDLE

Catalog Number	STCVC2040B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, while a "resident" was placing a cvc line on (b)(6) 2026 they "extracted the guidewire back through the introducer needle" causing the guidewire to "fall apart".The customer reported that the resident then "used the other end of the guidewire (blunt with no j loop)" and fed it through the introducer needle causing the guidewire to "perforate the patient's superior vena cava".The customer reported that the "patient did survive".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.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 or Problem Description
According to the customer, while a "resident" was placing a cvc line on (b)(6) 2026 they "extracted the guidewire back through the introducer needle" causing the guidewire to "fall apart".The customer reported that the resident then "used the other end of the guidewire (blunt with no j loop)" and fed it through the introducer needle causing the guidewire to "perforate the patient's superior vena cava".
Additional Manufacturer Narrative
Update to d9: device not returned.Update to h3: device not evaluated.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.

• Brand Name: MEDLINE
• Common Device Name: DBD-TRIPLE LUMEN CVC 20CM BUNDLE
• 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: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24457758
• Report Number: 3004519921-2026-00007
• Device Sequence Number: 9273804
• Product Code: LRO
• UDI-Device Identifier: 10653160372271
• UDI-Public: 10653160372271
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: STCVC2040B
• Device Lot Number: 2025072590
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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