MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/11/2023

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported by customer via medwatch, "powerloc max 20g 1 inch inserted 2023.Suspected lot asgzfc004.Inserted in patient's port, infusing chemo, found completely sperated before y-port.Chemo/blood spill." additional information received (b)(6) 2023: patient receiving chemo through a chest port.This rn walked into the room and noticed port needle tubing was torn at the first connection.Chemo was immediately paused.There was a small amount of chemo and blood that back-flowed from port tubing onto patient's shirt.The needle tubing could not be fixed therefore, pt was re-accessed and chemo was restarted.Chemo paused for a total of 45 minutes.F/u power loc max 20g 1 inch inserted (b)(6) 2023.Found completely separated before y-port.

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 a break is confirmed; however, the exact cause is unknown.One photograph of a 20 g powerloc max with a y-site was returned for evaluation.An initial visual observation of the photograph showed a break in the tubing of the sample, just distal to the y-site.Evidence of use was observed on the sample in the returned photograph.No details of the break site could be discerned from the returned photograph.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

Event Description

It was reported by customer via medwatch, "powerloc max 20g 1 inch inserted 2023.Suspected lot asgzfc004.Inserted in patient's port, infusing chemo, found completely sperated before y-port.Chemo/blood spill." additional information received (b)(6) 2023: patient receiving chemo through a chest port.This rn walked into the room and noticed port needle tubing was torn at the first connection.Chemo was immediately paused.There was a small amount of chemo and blood that back-flowed from port tubing onto patient's shirt.The needle tubing could not be fixed therefore, pt was re-accessed and chemo was restarted.Chemo paused for a total of 45 minutes.F/u power loc max 20g 1 inch inserted (b)(6) 23.Found completely separated before y-port.

Event Description

It was reported by customer via medwatch, "powerloc max 20g 1 inch inserted 2023.Suspected lot asgzfc004.Inserted in patient's port, infusing chemo, found completely sperated before y-port.Chemo/blood spill." additional information received 01/16/2023: patient receiving chemo through a chest port.This rn walked into the room and noticed port needle tubing was torn at the first connection.Chemo was immediately paused.There was a small amount of chemo and blood that back-flowed from port tubing onto patient's shirt.The needle tubing could not be fixed therefore, pt was re-accessed and chemo was restarted.Chemo paused for a total of 45 minutes.F/u power loc max 20g 1 inch inserted (b)(6) 2023.Found completely separated before y-port.

Manufacturer Narrative

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.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18575705
• MDR Text Key: 334752761
• Report Number: 3006260740-2024-00178
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047350
• UDI-Public: (01)00801741047350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: 0132010
• Device Lot Number: ASGZFC004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: 3 YR
• Patient Sex: Male