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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of aseqf123 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by patient "i have a home health nurse who comes to my house to access me.On wednesday, she used a new needle & when i hooked up to the pump is started leaking so i went to gravity flow & it was still leaking.I got in with a surgeon yesterday as an emergency & he couldn't change it because he didn't have any needles in supply & i didn't have mine with me.Surgeon said it was in place, flushed it with saline & got blood return.He assumed where the tubing connecting to the needle wasn't attached correctly.Additional information received 04/12/2022: it was stated that the needle was removed wednesday about 6 pm (b)(6) 2022.
Additional Manufacturer Narrative
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 leaking infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 20ga x 1¿ powerloc safety infusion set.Usage residues were observed throughout the sample.The safety mechanism was engaged and a needleless injection cap was attached to the luer adapter.Microscopic inspection of the sample did not reveal any evidence of current or previous leakage.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) pressurization of the sample.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by patient "i have a home health nurse who comes to my house to access me.On wednesday, she used a new needle & when i hooked up to the pump is started leaking so i went to gravity flow & it was still leaking.I got in with a surgeon yesterday as an emergency & he couldn't change it because he didn't have any needles in supply & i didn't have mine with me.Surgeon said it was in place, flushed it with saline & got blood return.He assumed where the tubing connecting to the needle wasn't attached correctly.Additional information received 04/12/2022: it was stated that the needle was removed wednesday about 6 pm (b)(6) 2022.

• Brand Name: POWERLOC SAFETY INFUSION 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14251159
• Report Number: 3006260740-2022-01572
• Device Sequence Number: 14674404
• Product Code: FPA
• UDI-Device Identifier: 00801741047923
• UDI-Public: (01)00801741047923
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 0672010
• Device Lot Number: ASEQF123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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