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 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 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.
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 second 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.
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 second device.Additional information received on (b)(6) 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 second 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
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 customer reported two leaking needles however only returned one device initially for evaluation.The evaluation for the first device has been submitted under medwatch report 3006260740-2023-01134.This report is to address the second device that was returned at a later date.The complaint of a leak is confirmed and was determined to be supplier related.Two 20 g powerloc max infusion sets were returned for evaluation.Functional testing of the samples showed a leak near the housing in each sample.A microscopic observation revealed voids and gaps in the adhesive within the needle housing of both samples.This sparse adhesive coverage allowed for leakage and likely occurred during manufacture of the devices at the supplier facility.The supplier has been notified and bd is working closely with the supplier facility to prevent recurrence of the reported event.This complaint will be recorded for future trending and monitoring purposes.

• 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): 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: 16668283
• Report Number: 3006260740-2023-01135
• Device Sequence Number: 20351546
• 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): 11/03/2023

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; 10/30/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/05/2023; 11/07/2023
• 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