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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that powerloc port access needle is leaking from the tubing.Additional information received 4/3/24: it was reported by the customer "the powerloc needle was primed with saline and no issue was noted.The patient's port was accessed with this needle and it was noted that for about every 3-4 mls of saline that was flushed through, 1 drop would form on the top of needle and drip out where it wasn't supposed to.The needle was removed from the patient and a new port needle was used to access the patient without issue.This could have been an adverse event since the patient received chemotherapy that day, though the needle with the defect was removed after only being accessed into the patient for a few seconds." no other information was provided.
Event or Problem Description
It was reported by the customer that powerloc port access needle is leaking from the tubing.Additional information received 4/3/2024: it was reported by the customer "the powerloc needle was primed with saline and no issue was noted.The patient's port was accessed with this needle and it was noted that for about every 3-4 mls of saline that was flushed through, 1 drop would form on the top of needle and drip out where it wasn't supposed to.The needle was removed from the patient and a new port needle was used to access the patient without issue.This could have been an adverse event since the patient received chemotherapy that day, though the needle with the defect was removed after only being accessed into the patient for a few seconds." no other information was provided.
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 leaking infusion set was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 20g powerloc infusion set.The investigation findings were consistent with improper or insufficient adhesive application or curing during manufacture of the component.The returned product sample was evaluated and a leak was observed at the distal end of the needle housing.This investigation concluded that the adhesive had not established a sufficient bond between the needle and the needle housing, and the characteristics observed which supported this type of failure included: ¿ the needle swiveled easily within the needle housing which indicated a firm bond did not exist ¿ voids or gaps in adhesive coverage were observed on the needle shaft.This is a supplied component and the supplier has been notified of this event.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• 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: kayla bevins ; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780 ; 8999213000
• MDR Report Key: 19195637
• Report Number: 3006260740-2024-01945
• Device Sequence Number: 8481037
• Product Code: FPA
• UDI-Device Identifier: 00801741047763
• UDI-Public: (01)00801741047763
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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 Model Number: N/A
• Device Catalogue Number: 0652034
• Device Lot Number: ASHQFC011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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 Sex: Unknown