MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.
Event or Problem Description
It was reported "port access needle cracked horizontally at the luer lock of the preattached connector." 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 complaint of a cracked connector is confirmed, but the exact cause could not be determined.One 20 ga x 1 in safestep infusion set was returned for evaluation.An initial visual observation showed blood use residues throughout the returned infusion set, and a purple marker was used to draw on the y-site luer.A microscopic observation revealed a split in the valved y-site.The fracture surface of the split was further observed by inserting a tapered syringe into the valved y-site.The fracture surface appeared smooth, but the edges of the split appeared uneven.The complaint of a cracked valved y-site is confirmed based on microscopic observations, but a root cause could not be determined.Possible contributing factors include over-tightening, forceful insertion of a tapered object into the luer connector hub, and material embrittlement due to exposure to incompatible chemicals and/or other environmental conditions.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "port access needle cracked horizontally at the luer lock of the preattached connector." no other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 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 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16746798
• Report Number: 3006260740-2023-01333
• Device Sequence Number: 8528065
• Product Code: FPA
• UDI-Device Identifier: 00801741066238
• UDI-Public: (01)00801741066238
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/12/2023

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: LH-0032YN
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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