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 Problem Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/25/2023

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 for evaluation.

Event Description

It was reported that the base was pushed down to the needle tip and the needle was removed, but the safety mechanism was not activated, and the needle tip was slightly protruding.Patient at home self-extracted the needle.There was a reported patient injury.

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.

Event Description

It was reported that the base was pushed down to the needle tip and the needle was removed, but the safety mechanism was not activated, and the needle tip was slightly protruding.Patient at home self-extracted the needle.There was a reported patient injury.Additional information received 29 november 2023: the needle tip was slightly stuck in the patient's hand.

Event Description

It was reported that the base was pushed down to the needle tip and the needle was removed, but the safety mechanism was not activated, and the needle tip was slightly protruding.Patient at home self-extracted the needle.There was a reported patient injury.Additional information received 29 november 2023: the needle tip was slightly stuck in the patient's hand.

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 broken safety mechanism is inconclusive because of the returned condition of the sample.One 22 ga x 0.75 in.Safestep infusion set without y-site was returned for evaluation.An initial visual observation revealed use residues throughout the returned infusion set.The safety mechanism was completely engaged upon the return of the device.A functional test of disengaging the safety mechanism and reengaging the safety mechanism revealed the safety slid down the needle shaft completely over the needle shaft as intended.A microscopic observation revealed no excessive adhesive along the metal sleeve of the safety mechanism.Nothing remarkable was observed during a microscopic observation of the device.Because the safety mechanism appeared to be completely engaged over the needle tip, the complaint of a broken safety mechanism is inconclusive.Possible observed causes of failure may include unknown clinical factors during use of the infusion set.This complaint will be recorded for future trending and monitoring purposes.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18216236
• MDR Text Key: 329120339
• Report Number: 3006260740-2023-05370
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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
• Device Lot Number: ASGWFC004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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