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	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by medwatch that patient admitted to in-patient care (b)(6) 2024.Rn called to patient room by mother around 11:55 (b)(6) 2024.Per mother, patient was moving around and pac needle broke right about q-syte.Statlock was in place at this time and pac needle tubing was still secured in place even after q-syte and iv tubing broke off.Blood seen backed up into residual port needle.Rn clamped pac needle and de-accessed port.Apn made aware and rn will hang new bag of blina at same rate when available from pharmacy.Chemo spill kit will come clean room shortly.Patient's pac re-accessed and new blinatumomab bag hung.Mother washed patient and herself well per advice from pharmacist.No skin irritation noted to patient's skin.Patient playing comfortably with mother at this time.Apn updated.No new orders at this time.No other information was provided.Additional information: complicated by line infection (b)(6).Has port that was able to be spared with antibiotics and infection has been treated.Has picc line placed (b)(6) for chemotherapy usage, line was lost (b)(6), now chemotherapy has returned to being infused via port.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: 20825387
• Report Number: 3006260740-2024-07150
• Device Sequence Number: 7831930
• 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: 12/02/2024
• 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: 16 MO
• Patient Sex: Male
• Patient Weight: 12 KG
• Patient Ethnicity: Hispanic
• Patient Race: White