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); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
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.Possible lot asgzfc004.Inserted in patient's port, chemo infusing, found completely separated before y port.Chemo and blood spill.This is the 3rd incident with this same product type/lot in 24 hours.This is the fifteenth incident year to date this unit has experiences at hospital.We now stopped using this product.We have made numerous reports to the manufacturer and the fda regarding the integrity of the y-port connection on this product and significant impairment exists.Patient risks infection, blood loss (open line), and leakage of infusate (in these cases it has been chemo)." additional information received 01/16/2024: found completely separated before y-port.Followup: product removed and swapped for power loc (no side 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 in the infusion set is confirmed; however, the exact cause is unknown.One photograph of a powerloc max was returned for evaluation.An initial visual observation of the photograph showed a 20 g powerloc max which had a disconnection between the tubing and the y-site.Use residue was observed on the sample, and it was also observed that the safety was engaged.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 1inch inserted 2023 possible lot asgzfc004.Inserted in patient's port, chemo infusing, found completely separated before y-port.Chemo and blood spill.This is the 3rd incident with this same product type/lot in 24 hours.This is the fifteenth incident year to date this unit has experiences at hospital.We now stopped using this product.We have made numerous reports to the manufacturer and the fda regarding the integrity of the y-port connection on this product and significant impairment exists.Patient risks infection, blood loss (open line), and leakage of infusate (in these cases it has been chemo)." additional information received 01/16/2024: found completely separated before y-port.Follow-up: product removed and swapped for power loc (no side port).
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.This complaint was received as part of a clinical survey.Contact information and specific patient details were not disclosed as part of the survey.As such, additional information and the subject sample cannot be obtained.
Event or Problem Description
It was reported by customer via medwatch, "powerloc max 20g 1inch inserted 2023 possible lot asgzfc004.Inserted in patient's port, chemo infusing, found completely separated before y-port.Chemo and blood spill.This is the 3rd incident with this same product type/lot in 24 hours.This is the fifteenth incident year to date this unit has experiences at hospital.We now stopped using this product.We have made numerous reports to the manufacturer and the fda regarding the integrity of the y-port connection on this product and significant impairment exists.Patient risks infection, blood loss (open line), and leakage of infusate (in these cases it has been chemo)." additional information received 01/16/2024: found completely separated before y-port.Follow-up: product removed and swapped for power loc (no side port).

• 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: 18575049
• Report Number: 3006260740-2024-00175
• Device Sequence Number: 7852319
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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: 01/16/2024
• 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; 03/05/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/15/2024
• 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: Unknown