MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD STATLOCK ARTERIAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/08/2023

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by customer that while working with patient, we re-zeroed the line and i left the room.I noticed on the monitor that the a-line was not reading, i went in to assess the patient was bleeding from underneath dressing and when removing the dressing, tubing was detached from patient/catheter.

Manufacturer Narrative

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 complaint of a leak was inconclusive because the damaged component is not a bd product.The product returned for evaluation was one statlock arterial extension set with an attached 3-way valve.An iv catheter attached to a statlock and a green cap was also returned.Use residue was observed on the iv catheter and statlock.An attempt to flush the device with water using a 12ml syringe revealed a leak on 3-way valve.Microscopic inspection of the 3-way valve revealed a crack.Microscopic inspection of the extension set was unremarkable.The 3-way valve exhibited damage; however, as this is not a bd product, the allegation of bd product defect is considered inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported by customer that while working with patient, we re-zeroed the line and i left the room.I noticed on the monitor that the a-line was not reading, i went in to assess the patient was bleeding from underneath dressing and when removing the dressing, tubing was detached from patient/catheter.

• Brand Name: BARD STATLOCK ARTERIAL
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18490378
• MDR Text Key: 333096062
• Report Number: 3006260740-2023-06117
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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