MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; 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	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by nurse ¿patient had the device inserted on (b)(6) 2022 and left over night for treatment.When the nurse went to flush the line on (b)(6), there was leaking out of the tubing, no type of harm involved.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asgnf076 showed no other similar product complaint(s) from this lot number.
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), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be supplier related.Two 19 g x 0.75 in.Powerloc max infusion sets with non-valved y-sites were returned for evaluation.An initial visual observation showed use residue on one sample and the other sample was returned in a sealed package.Needleless injection caps were returned on both luer hubs of the used sample, and the safety mechanism of this sample was observed to be engaged.A large longitudinal crack was observed in the y-site of the used sample between the two branches of the y-site on the larger branch.A microscopic observation revealed a distinct knit/weld line in the y-site of the sample returned in a sealed package.Micro-fractures were observed in the used sample around the large crack in the y-site.The device is a supplied component, and the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by nurse ¿patient had the device inserted on (b)(6) 2022 and left over night for treatment.When the nurse went to flush the line on (b)(6), there was leaking out of the tubing, no type of harm involved.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• 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: 15065113
• Report Number: 3006260740-2022-02807
• Device Sequence Number: 5529991
• Product Code: FPA
• UDI-Device Identifier: 00801741047343
• UDI-Public: (01)00801741047343
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 0131975
• Device Lot Number: ASGNF076
• 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: 09/21/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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