MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Crack (1135)

Patient Problem Chemical Exposure (2570)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It was reported by the customer that "patient called care coordinator rn this morning to inform the cadd solis pump was leaking.The patient stopped the pump and wrapped the pump in multiple bags.Patient arrived to facility and 3 rns assessed patient and pump.Pump and tubing was intact, tightened and taped appropriately.Nurses noticed a crack in the huber tubing at y-site closest to patient approximately 0.5cm long.Patient noticed leaking around 8pm last night.Patient denies issues or injury prior.Huber needle and pump removed.Per providers, continue infusion for 24 hours with remaining dose.Pharmacy prepared new cassette with new tubing.Remaining chemo disposed in correct bin.Port re-accessed on 1/25.New pump connected and infusing without issue.No noted leaking noted.Patient re-educated to call with any concerns, questions, or issues.Additional information received on 2/8/2023: patient came in to have 5fu (chemotherapy) pump discontinued.The port needle had been dressed with a biopatch and secured with steristrip for reinforcement.The connection around the tubing and microclaved were taped.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of asgsfc099 showed four other similar product complaint(s) from this batch number.

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 history, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a crack in the y-site was confirmed and appeared to be supplier related.A single photograph of a damaged y-site, reportedly from the implicated 20g x ¾¿ powerloc safety winged infusion set, was returned for evaluation of this complaint.A longitudinal crack was observed in the y-site.The crack was located on the inner side of the threaded branch of the y-site.The crack was observed to extend from the orifice of the luer connector to approximately half-way to the elbow of the y-site.The crack location appeared consistent with the molding knit/weld line.The supplier has been notified of this event, and bd is working closely with the supplier to prevent recurrence of the reported event.

Event Description

It was reported by the customer that "patient called care coordinator rn this morning to inform the cadd solis pump was leaking.The patient stopped the pump and wrapped the pump in multiple bags.Patient arrived to facility and 3 rns assessed patient and pump.Pump and tubing was intact, tightened and taped appropriately.Nurses noticed a crack in the huber tubing at y-site closest to patient approximately 0.5cm long.Patient noticed leaking around 8pm last night.Patient denies issues or injury prior.Huber needle and pump removed.Per providers, continue infusion for 24 hours with remaining dose.Pharmacy prepared new cassette with new tubing.Remaining chemo disposed in correct bin.Port re-accessed on 1/25.New pump connected and infusing without issue.No noted leaking noted.Patient re-educated to call with any concerns, questions, or issues.Additional information received on 2/8/2023: patient came in to have 5fu (chemotherapy) pump discontinued.The port needle had been dressed with a biopatch and secured with steristrip for reinforcement.The connection around the tubing and microclaved were taped.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN 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 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16390680
• MDR Text Key: 310147026
• Report Number: 3006260740-2023-00477
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047947
• UDI-Public: (01)00801741047947
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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: 0672034
• Device Lot Number: ASGSFC099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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