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
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem 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.
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 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 or Problem 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 or Problem 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.
Additional 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
• 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 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18575705
• Report Number: 3006260740-2024-00178
• Device Sequence Number: 12993322
• Product Code: FPA
• UDI-Device Identifier: 00801741047350
• UDI-Public: (01)00801741047350
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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 Expiration Date: 11/30/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/05/2024; 03/11/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/04/2024; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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 Age: 3 YR
• Patient Sex: Male