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

Catalog Number	0671910
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that recently had an incident with a patient¿s port tubing coming apart (severed) or crack completely off while home-chemo 5fu was being infused.The port needle remained intact but the tubing was completely severed off in the dressing allowing for leakage of chemo, bleeding from the tubing, unable to clamp the port needle due to the disconnection of the tubing with the clamp was no longer connected or intact with an opportunity for an infection to enter.Patient presenting to treatment area with 5fu cadd pump connected for ivf and repeat lab work.Per patient, port tubing had come "disconnected" at home overnight while 5fu infusing and she reports having "reconnected" tubing after waking up and seeing blood on her bed sheets from port tubing.No residual 5fu noted on patient's skin.Cadd pump stopped and upon inspection of port, port tubing had severed above proximal lumen.Patient disconnected from cadd pump and port deaccessed.Upon discussion w/ app, cadd pump not to be reconnected and okay to reaccess port for ivf and lab work.No further interventions needed regarding severed tubing per app.
Event or Problem Description
It was reported by customer that recently had an incident with a patient¿s port tubing coming apart (severed) or crack completely off while home-chemo 5fu was being infused.The port needle remained intact but the tubing was completely severed off in the dressing allowing for leakage of chemo, bleeding from the tubing, unable to clamp the port needle due to the disconnection of the tubing with the clamp was no longer connected or intact with an opportunity for an infection to enter.Patient presenting to treatment area with 5fu cadd pump connected for ivf and repeat lab work.Per patient, port tubing had come "disconnected" at home overnight while 5fu infusing and she reports having "reconnected" tubing after waking up and seeing blood on her bed sheets from port tubing.No residual 5fu noted on patient's skin.Cadd pump stopped and upon inspection of port, port tubing had severed above proximal lumen.Patient disconnected from cadd pump and port deaccessed.Upon discussion w/ app, cadd pump not to be reconnected and okay to reaccess port for ivf and labwork.No further interventions needed regarding severed tubing per app.
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 complaint of disconnection of infusion set tubing is confirmed and was determined to be supplier related.One 19 ga x 1.0 in.Powerloc infusion set was returned for evaluation.An initial visual observation of the returned infusion set revealed blood use residues throughout the returned device.The tubing of the device was completely broken just distal of the y-site valve.A tactile evaluation revealed no tensile weakness along the tubing of the device.A test of attempting to re-insert the tubing back into the y-site luer revealed the tubing fit to the end of the y-site.A microscopic observation revealed striations along the proximal end of the tubing.No tubing was observed inside the y-site cavity.A uv light revealed inadequate adhesive inside the y-site cavity and along the tubing insertion site.The failure of the device tubing was determined to be related to the manufacture of the device.The device is a supplied component and the supplier has been notified of this event.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G 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 UT 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19991576
• Report Number: 3006260740-2024-04490
• Device Sequence Number: 12876941
• Product Code: FPA
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893(11)240404(17)270604(10)ASHZFC021
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 0671910
• Device Lot Number: ASHZFC021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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