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

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

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 device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.

Event Description

It was reported via medwatch that rn noted arterial line alarm "disconnect" and went into the patient's room to assess the situation and observed blood at site of the arterial line.The rn performed visual inspection and identified that the arterial line had broken off at the hub into catheter insertion.The remaining catheter was removed from the artery and pressure held to stop the bleeding.No other information provided.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION W/STOPCOCK
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17482900
• MDR Text Key: 321069356
• Report Number: 3006260740-2023-03390
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741081378
• UDI-Public: (01)00801741081378
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: 07/25/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White