MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Exsanguination (1841)

Event Date 06/14/2023

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

Event Description

It was reported by customer that had 5 instances of the connection breaking off causing a considerable amount of blood loss to the patient.This report addresses the first device.

Event Description

It was reported by customer that had 5 instances of the connection breaking off causing a considerable amount of blood loss to the patient.This report addresses the first device.

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 complaint of a detached luer lock adaptor was confirmed and appears to be manufacturing related.Two photos of a used extension set were returned for evaluation.The male luer lock adapter has been separated from the extension tubing.What appeared to be an adhesive fillet was observed on the extension tubing.No tubing appeared to be present within the luer lock adapter, indicating that the tubing likely dislodged rather than broke.It appeared that the adhesive joint between the components failed.The returned photos exhibited the same features as a known issue h3 other text : evaluation findings are in section h11.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX
• 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: 17262606
• MDR Text Key: 318607319
• Report Number: 3006260740-2023-02771
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: ART0420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• 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