MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Material Deformation (2976); Activation Problem (4042)

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

Event Date 11/16/2023

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.H3 other text : device not returned.

Event Description

It was reported that when tried to remove the needle as usual during the extraction, the safety mechanism did not work.There was no reported patient injury.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.The complaint of difficulty advancing the safety mechanism is confirmed and was determined to be use-related.One 22 ga x 0.75 in.Safestep infusion set needle housing was returned for evaluation.An initial visual observation showed use residues throughout the returned infusion set housing.A functional test of attempting to advance the safety mechanism down the needle shaft was difficult.Using substantial force, the safety mechanism advanced past the needle tip.A microscopic observation revealed the distal tip of the needle to be bent.An observation of the needle shaft after the safety mechanism was advanced revealed the needle shaft to be severely bent.Because the needle tip was observed to be bent and a bend in the needle shaft was observed, the complaint of difficulty advancing the safety mechanism is confirmed and was determined to be use-related.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported that when tried to remove the needle as usual during the extraction, the safety mechanism did not work.There was no reported patient injury.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18266369
• MDR Text Key: 329725436
• Report Number: 3006260740-2023-05494
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153440
• 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: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: LH-0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2024
• 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