MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.

Event Description

It was reported by the customer disconnection of the luer lock from the extension tubing from statlock product.No other information was provided.

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.Based on a review of this information, the following was concluded: the complaint of a detached luer connector is confirmed; however, the root cause could not be determined.One photograph of an extension set with a y-site and an iv select statlock kit was returned for evaluation.An initial visual observation of the photograph showed an extension set with a y-site.The luer connector was observed to be detached from the distal end of the extension tube.What appears clear fluid in the tube was observed in the returned photograph.Although the detached luer connector was evident in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported by the customer disconnection of the luer lock from the extension tubing from statlock product.No other information was provided.

• Brand Name: STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18634694
• MDR Text Key: 334793420
• Report Number: 3006260740-2024-00322
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741082047
• UDI-Public: (01)00801741082047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: IV0564
• Device Lot Number: JUHX8593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• 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