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

Catalog Number CPA00052

Device Problem Fluid/Blood Leak (1250)

Patient Problems Emotional Changes (1831); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported by the customer when they were priming the line they noticed product leaking at junction between tubing and needle.No other information was provided.

Event Description

It was reported by the customer when they were priming the line, they noticed product leaking at junction between tubing and needle.Additional information received on 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.

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 Description

It was reported by the customer when they were priming the line, they noticed product leaking at junction between tubing and needle.Additional information received on 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.

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
• Type of Device: 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16702581
• MDR Text Key: 312896600
• Report Number: 3006260740-2023-01237
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741182150
• UDI-Public: (01)00801741182150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: CPA00052
• Device Lot Number: REGW3691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female