MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; 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	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "we have had four huber needles leak on the hub end." no other information was provided.This report addresses the first device.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) 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.
Event or Problem Description
It was reported by the customer "we have had four huber needles leak on the hub end." no other information was provided.This report addresses the first device.Additional information received (b)(6) 2022: the only risk to the patient was that they need to have their port recannulated.
Event or Problem Description
It was reported by the customer "we have had four huber needles leak on the hub end." no other information was provided.This report addresses the first device.Additional information received 12/27/2022: the only risk to the patient was that they need to have their port recannulated.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking y-site is confirmed and was determined to be supplier related.One 19 ga x 0.75¿ powerloc max with a needleless injection cap attached was returned for evaluation.A functional test involved removing the needleless injection cap and inserting a 12 ml slip-fit syringe at the y-site connection area was performed.Water was injected into the device, and this revealed the crack at the y-site adjacent to the molding seam.A microscopic observation revealed the split to be longitudinally aligned with the molding seam.Whitening around the split was observed with the slip-fit syringe still inserted into the powerloc max y-site.The complaint of the powerloc max device leaking at the y-site is confirmed as this is a known supplier issue.The supplier was notified of this event, and bd is working closely with the supplier to prevent recurrence of the reported event.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• 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: 16071065
• Report Number: 3006260740-2022-05919
• Device Sequence Number: 6294910
• Product Code: FPA
• UDI-Device Identifier: 00801741047329
• UDI-Public: (01)00801741047329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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: 0131910
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 12/27/2022; 02/22/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/13/2023; 02/23/2023
• 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