MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTRAVASCULAR CATHETER (20G); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Date 11/19/2022

Event Type  malfunction  

Event Description

It was reported by the customer "the needle on the accucath device did not retract when the button was activated" it was reported this occurred with two devices.This report addresses the first device.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regs4108 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (regs4108) have been reported from the same facility.

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 available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of safety mechanism failures was unconfirmed because the problem could not be reproduced.The product returned for evaluation was two 20ga x 2.25¿ accucath ace peripheral iv catheter assemblies.The samples were received with their original opened packages.Both samples were received with the catheters advanced and neither catheter was returned for evaluation.The safety buttons were activated and both needles were fully withdrawn into the housings.Microscopic inspection of the samples revealed that all of the components appeared well formed and unremarkable.The safety buttons, springs, needle carriers and needle retention features were undamaged and functioned as intended.Both safety mechanisms were disengaged and the needles were reset.Subsequent activation of both safety mechanism was successful and unremarkable.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer "the needle on the accucath device did not retract when the button was activated" it was reported this occurred with two devices.This report addresses the first device.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (20G)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15954872
• MDR Text Key: 307087796
• Report Number: 3006260740-2022-05666
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162894
• 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: 04/13/2023

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REGS4108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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