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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
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 complaint of a bent needle of an infusion set is confirmed but the exact cause could not be determined.One 22 ga x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation revealed no obvious use residues throughout the returned infusion set.It was observed that the needle of the returned infusion set was bent at the proximal end of the exposed needle.The safety mechanism was observed to have a crack on one side of the needle and was not advanced over the needle tip.The needle cover was returned attached to the needle shaft.An attempt to carefully slide the broken safety mechanism down the bent needle shaft revealed the safety mechanism would not advance.A microscopic observation revealed no obvious scratches along the needle shaft.The crack in the safety mechanism appeared to have a brittle, uneven fracture surface.The metal ring inside the safety mechanism was observed to be bent and exposed outside the plastic housing.Because the infusion set was returned opened, a cause could not be determined for the bent needle.Potential causes of failure for the break in the safety mechanism may include storage conditions, attempted use of the safety mechanism with a bent needle, or other unknown factors.Potential causes of failure for the bent needle may include storage conditions or other unknown factors.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that the needle looks bending and there's a resistance while priming the tube.No other information was provided.09/25/2024 - during evaluation of the returned device, the safety mechanism was found to be cracked and unable to be advanced over the needle.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE
• 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 UT 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20484524
• Report Number: 3006260740-2024-06002
• Device Sequence Number: 11786086
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177(11)221219(17)250929(10)ASGWFC131
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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: 09/29/2025
• Device Model Number: N/A
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASGWFC131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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