MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Emotional Changes (1831); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional 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 device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.
Event or Problem Description
It was reported by the customer, the huber needle is leaking when flushed at the c shaped piece that is used to remove the needle.The needle has to be removed and the patient re accessed.It was reported this occurred with two devices.This report addresses the first device.
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 the customer, "the huber needle is leaking when flushed at the c shaped piece that is used to remove the needle.The needle has to be removed and the patient re-accessed." it was reported this occurred with two devices.This report addresses the first device.Additional information received 4/20/2023: customer states the events were non life threatening.Leaks were discovered when flushed immediately after insertion.It causes an interruption in care and delay in treatment.The needle must be removed.Staff must perform the entire sterile process again and re-access the patient.This causes anxiety and fear that the needle will leak again once the chemo begins to infuse for the patients.
Event or Problem Description
It was reported by the customer, "the huber needle is leaking when flushed at the c shaped piece that is used to remove the needle.The needle has to be removed and the patient re-accessed." it was reported this occurred with two devices.This report addresses the first device.Additional information received 4/20/2023: customer states the events were non life threatening.Leaks were discovered when flushed immediately after insertion.It causes an interruption in care and delay in treatment.The needle must be removed.Staff must perform the entire sterile process again and re-access the patient.This causes anxiety and fear that the needle will leak again once the chemo begins to infuse for the patients.
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 leak in the needle housing was confirmed and the cause was determined to be supplier related.The product returned for evaluation was 20g x 1"" powerloc max infusion set.The investigation findings were consistent with improper or insufficient adhesive application or curing during manufacture of the component at the supplier facility.The returned product sample was evaluated and a leak was observed where the tubing connects to the needle housing.This investigation concluded that the adhesive had not established a sufficient bond between the extension tubing and the needle shaft, and the characteristics observed which supported this type of failure included: ¿ air bubbles or voids in adhesive coverage were seen in the application wells ¿ voids or gaps in adhesive coverage were observed on the needle shaft the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH WITH Y-SITE
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16668271
• Report Number: 3006260740-2023-01134
• Device Sequence Number: 12255531
• Product Code: FPA
• UDI-Device Identifier: 00801741182150
• UDI-Public: (01)00801741182150
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CPA00052
• Device Lot Number: REGW3691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 07/05/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/05/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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 Sex: Unknown