MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION WITH STOPCOCK SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.

Event Description

It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information 9/15: we have reviewed and, in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the fourth device.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION WITH STOPCOCK SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17798664
• MDR Text Key: 324036612
• Report Number: 3006260740-2023-04242
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ART0421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other