MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

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 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 manufacturer has received the sample and is pending evaluation.Results are expected soon.

Event Description

It was reported that there was a leak, around the y-site end area of the port tubing.Patient receiving immunotherapy and completed it, staff noticed leakage at the site prior to connecting to pump.Changed the entire port needle and no further leakage noted.Received medication from pump.No other information provided.Additional information received (b)(6) 2023: it was reported there is interruption of administration of medication/cause a clinically significant delay in medication that negatively impacted the patient.Patient did not receive all prescribed chemo for cancer regimen, patient was exposed to the chemo.Chemo exposure, no harm.

Event Description

It was reported that there was a leak, around the y-site end area of the port tubing.Patient receiving immunotherapy and completed it, staff noticed leakage at the site prior to connecting to pump.Changed the entire port needle and no further leakage noted.Received medication from pump.No other information provided.Additional information received 8/21/2023: it was reported there is interruption of administration of medication/cause a clinically significant delay in medication that negatively impacted the patient.Patient did not receive all prescribed chemo for cancer regimen, patient was exposed to the chemo.Chemo exposure, no harm.

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.Based on a review of applicable information, the following was concluded: the complaint of a crack in the y-site was confirmed as supplier related.The returned sample was found to exhibit the same features as a known issue.The returned product was a 19g x 1¿ powerloc safety infusion set.The y-site luer adaptor contained a longitudinal crack traversed from the orifice of the connector to the mold indicator.The crack in the y-site luer adaptor leaked when the sample was flushed.This event was likely related to a known supplier related issue.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
• Type of Device: 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 UT 84116
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17626975
• MDR Text Key: 321992419
• Report Number: 3006260740-2023-03705
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0671910
• Device Lot Number: ASGYFC003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female