MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when tried to remove the needle, the base did not lower and the safety mechanism did not work.There was no reported patient injury.No other information was provided.
Additional 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.
Additional Manufacturer Narrative
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 defective safety mechanism is confirmed and was determined to be supplier related.One 22 g safestep infusion set was returned for evaluation.An initial visual observation showed the safety mechanism of the device was not activated.An attempt to activate the safety mechanism of the device was unsuccessful, and the safety mechanism was found to be stuck to the needle housing.A microscopic observation revealed excessive adhesive at the base of the needle where it exits the needle housing.Once the safety mechanism was moved by force, adhesive was observed to be stuck to the metal sleeve of the safety mechanism, which prevented the safety mechanism from successfully activating.This device is a supplied component, and the supplier has been notified of this event via (b)(4).This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that when tried to remove the needle, the base did not lower and 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 0.5IN
• Common Device Name: 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19449307
• Report Number: 3006260740-2024-02748
• Device Sequence Number: 3264568
• Product Code: FPA
• UDI-Device Identifier: 00801741066283
• UDI-Public: (01)00801741066283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2026
• Device Model Number: N/A
• Device Catalogue Number: LH-0035
• Device Lot Number: ASHPFC149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown