MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20G X 0.75" SAFESTEP INFUSION SET WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that these needles "very difficult to remove safely without engaging safety." customer has been using the safestep huber needles previously, is asking if there is a difference between the two devices when removing from the ivad that could be contributing to these challenges.Customer states this is not causing unexpected or prolonged care.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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 safety mechanism failure was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set with y-site.Usage residues were observed throughout the sample.The safety mechanism was completely detached from the needle and was received loose.Microscopic inspection of the sample revealed that the metal sleeve was missing from the safety plate assembly.The yellow plastic collar did not exhibit significant deformation.The missing metal sleeve caused the observed safety mechanism detachment.The lack of plastic collar deformation suggested that the metal sleeve was omitted during device assembly.The device is a supplied component and the supplier has been notified of this event.
Event or Problem Description
Customer reports that these needles "very difficult to remove safely without engaging safety." customer has been using the safestep huber needles previously, is asking if there is a difference between the two devices when removing from the ivad that could be contributing to these challenges.Customer states this is not causing unexpected or prolonged care.Additional information received: customer reported no patient harm.

• Brand Name: 20G X 0.75" SAFESTEP INFUSION SET 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 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16503328
• Report Number: 3006260740-2023-00726
• Device Sequence Number: 3290659
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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