MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 18GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386801
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 18gx1.25in straight bc small piece of plastic or glue stuck inside the bevel of cannula.Small piece of plastic or glue stuck inside the bevel of cannula.Hss has received a product complaint from (b)(4) hospital, see product detail below: product: bd cathena 18ga 1.25 in.Supplier: (b)(4).Complaint: ["sterility/contamination or leakage issue","manufacturing fault?"] description: small piece of plastic or glue stuck inside the bevel of cannula.Action: discarded and used different item and inspected for foreign material.Took photos of product then discarded.Complainant: (b)(6).Contact number: (b)(6).Alternative contact: (b)(6).Is product available? no.Is packaging available? no.We request a solution to this complaint, along with replacement products or a credit reimbursement by the kpi deadline of 11 june 2024.All communications regarding this issue should also be emailed to mailto:hss.(b)(6).

• Brand Name: BD CATHENA 18GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19462176
• Report Number: 2243072-2024-00675
• Device Sequence Number: 6653078
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: (01)00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: 06/30/2025
• Device Catalogue Number: 386801
• Device Lot Number: 2174805
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown