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

Model Number N/A

Device Problem Crack (1135)

Patient Problem Chemical Exposure (2570)

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

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 will evaluate.Results are expected soon.A batch history review (bhr) of asgsfc099 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer, "huber needle leaked, 5fu cassette leaked from the y site farthest from the patient where the tubing was connected.The patient was access monday (january 23, 2023).".

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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, 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.One 20 g x 0.75 in.Powerloc infusion set with a non-valved y-site was returned for evaluation.An initial visual observation showed use residue on the returned sample.A large longitudinal crack was observed in the y-site between the two branches of the y-site.A microscopic observation revealed the crack appeared to begin along the knit line of the y-site.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, "huber needle leaked, 5fu cassette leaked from the y site farthest from the patient where the tubing was connected.The patient was accessed on monday, on (b)(6) 2023.".

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16376302
• MDR Text Key: 309562752
• Report Number: 3006260740-2023-00445
• Device Sequence Number: 1
• Product Code: LJT
• 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: 03/17/2023

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
• 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
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/23/2023
• 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