MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by medwatch patient butterfly pac tubing broke immediate proximal to q-site with continuous blinatumomab transfusion.Clamp fell off line and blood was back flowing from line.Unable to flush or heparinize due to cap getting disconnected.Patient de-accessed and re-accessed.This is the second occurrence of line shearing in same location.Clasbsi aca held 10/15 (incidentally right after this occurrence of line shear).Medwatch states blood culture was positive with klebsiella pneumonia.
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 received by the manufacturer for evaluation.

• Brand Name: MINILOC SAFETY INFUSION SET 19G X 0.75IN
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20815477
• Report Number: 3006260740-2024-07135
• Device Sequence Number: 9254118
• Product Code: FPA
• UDI-Device Identifier: 00801741047527
• UDI-Public: (01)00801741047527
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0631934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 17 MO
• Patient Sex: Male
• Patient Weight: 12 KG
• Patient Ethnicity: Hispanic
• Patient Race: White