MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asfxf043 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by nurse ¿on (b)(6) 2022, patient had the device connected to them for chemotherapy and the chemotherapy ended up leaking all over the chest wall, nurse cleaned up the chest wall and reported this issue to their physician and the site was then assessed the site, the patient received the rest of their dose.".
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked y-site luer hub was confirmed and the cause was supplier-related.The product returned for evaluation was one 19ga x 0.75¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample and needleless injection caps were attached to both luer adapters.A crack was observed in the y-site, opposite the molding gate.The crack appeared to originate at the luer orifice and propagated along a molding weld line in the material.Microscopic inspection of the y-site confirmed that the crack propagated along a weld line feature in the material.The crack exhibited a granular fracture surface.Abundant superficial stress fracturing was observed throughout the region of the y-site near the orifice.The crack occurred along a molding feature in the y-site material.The abundant stress fracturing was also indicative of material embrittlement, likely caused by manufacturing conditions.The device is a supplied component and the supplier has been notified of this event.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by nurse ¿on (b)(6) 2022, patient had the device connected to them for chemotherapy and the chemotherapy ended up leaking all over the chest wall, nurse cleaned up the chest wall and reported this issue to their physician and the site was then assessed the site, the patient received the rest of their dose.".

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 0.75IN 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15059097
• Report Number: 3006260740-2022-02774
• Device Sequence Number: 20039285
• Product Code: FPA
• UDI-Device Identifier: 00801741047916
• UDI-Public: (01)00801741047916
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 0671934
• Device Lot Number: ASFXF043
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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