MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 19G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
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.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that the mediport tubing was disconnected while connected to patient.No patient impact.Additional information received (b)(6) 2023: patient is a toddler, male.The event did not involve an urgent/life threatening medical situation.No negative outcome that occurred as a result of the event.Patient was post chemo infusion when incident occurred.No additional, unplanned medical or surgical intervention required.
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 is confirmed and was determined to be supplier related.One 19 ga x 1 in.Miniloc infusion set with y-site was returned for evaluation.Also returned is a 20g x 1" w/y-site miniloc infusion set.A microscopic observation revealed lack of adhesive between the tubing and the molded y-site.A uv light was used to identify the adhesive under the microscope.Because the infusion set was found to have lack of adhesive, the complaint of a leaking infusion set is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by customer that the mediport tubing was disconnected while connected to patient.No patient impact.Additional information received 01 aug 2023: patient is a toddler, male.The event did not involve an urgent/life threatening medical situation.No negative outcome that occurred as a result of the event.Patient was post-chemo infusion when incident occurred.No additional, unplanned medical or surgical intervention required.

• Brand Name: MINILOC SAFETY INFUSION SET 19G 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 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17491711
• Report Number: 3006260740-2023-03421
• Device Sequence Number: 15265589
• Product Code: FPA
• UDI-Device Identifier: 00801741047503
• UDI-Public: (01)00801741047503
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• 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
• Report Date (Section B): 04/01/2024

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: 0631910
• Device Lot Number: UNKNOWN
• 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: 07/23/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male