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 12/03/2022

Event Type  malfunction  

Event Description

It was reported that the needle didn't retract when activation button was pushed.No other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regv3338 showed one other similar product complaint(s) from this lot number.

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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, complaint and lot history, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a the needle not retracting into the housing was confirmed but the exact cause remains unknown.One 20 ga x 2.25 in accucath device was returned for evaluation.The open packaging label indicates lot: regv3338.Blood residue was present through the device externally and internally.The needle present and attached to the distal end of the device.The spring and needle assembly were found to freely move within the device.The proximal end of the spring appeared to have been properly disengaged from the button mechanism; however, the distal end of the spring was not retained at the distal end of the accucath plastic housing.Blood residue was present on the spring.The slider was manipulated in order to move the spring and needle assembly within the housing.The slider was fully advanced causing the spring to be compressed into the distal end of the housing.When the slider was released the spring was found to properly retract into the housing due to the spring locking into place at the distal end of the housing.The housing was disassembled in order to inspect the components.The spring was removed and the outer diameter at the distal end was measured.The outer diameter was found to be within manufacturing specification.Since the detachment of the spring from the distal end of the housing appeared to contribute to the needle not retracting, the complaint is confirmed; however, the exact cause remains unknown.

Event Description

It was reported that the needle didn't retract when activation button was pushed.No other information was provided.Additional information received: it was stated there was no patient harm and no treatment or intervention was needed due to the reported issue.

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 will evaluate.Results are expected soon.

Event Description

It was reported that the needle didn't retract when activation button was pushed.No other information was provided.Additional information received: it was stated there was no patient harm and no treatment or intervention was needed due to the reported issue.

• 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: 16075282
• MDR Text Key: 308278631
• Report Number: 3006260740-2022-05929
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 03/27/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REGV3338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/07/2023; 03/27/2023
• Supplement Dates FDA Received: 02/10/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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