MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 20G X 1 IN; 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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when puncturing the catheter (port a cath) and salinizing with the posiflush syringe, the nurse notices leaking between the probe and the connection.There was no harm to the patient.Patient in good general condition.The exact location of the leaking was between the probe connection and the pvc pipe.A physiological solution was being used at the time of the incident as the patient was being punctured for chemotherapy treatment.There was no need for medical intervention.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 device has not been returned to the manufacturer for evaluation.
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 device is confirmed and was determined to be supplier related.One 20 ga x 1.0 in.Miniloc infusion set was returned for evaluation.An initial visual observation revealed some saline use residues throughout the returned infusion set.A functional test of attempting to pressurize the infusion set with water using a 12 ml syringe revealed a leak at the tubing/needle housing interface.A microscopic observation revealed the leak at the tubing/needle housing interface to be caused by the tubing coming loose from the yellow needle housing.It was observed that the adhesive around the tubing/needle housing joint was failing as the tubing could be seen pulling out of the needle housing.The cause of the leak is likely due to insufficient adhesive curing at the tubing/needle housing joint during the manufacturing process.The device is a supplied component and the supplier has been notified of this event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported when puncturing the catheter (port a cath) and salinizing with the posiflush syringe, the nurse notices leaking between the probe and the connection.There was no harm to the patient.Patient in good general condition.The exact location of the leaking was between the probe connection and the pvc pipe.A physiological solution was being used at the time of the incident as the patient was being punctured for chemotherapy treatment.There was no need for medical intervention.No other information was provided.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 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 UT 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19826278
• Report Number: 3006260740-2024-04038
• Device Sequence Number: 15630593
• Product Code: FPA
• UDI-Device Identifier: 00801741047541
• UDI-Public: (01)00801741047541
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 03/14/2026
• Device Model Number: N/A
• Device Catalogue Number: 0632010
• Device Lot Number: ASHQFC068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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