MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML HEPARIN 100 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number 306424

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 03/07/2024

Event Type  Injury  

Event Description

Material#: 306424 lot#: unknown.It was reported by the customer that the patient has an infection in her port after receiving heparin.Verbatim: rcc received a complaint via phone.Pir attached.Patient has an infection in her port after receiving heparin.The infection she has is leclercia decarboxylate.The product number is 306424 but are unsure which lot she received as they have multiple lots in stock.Customer would like closure letter and acknowledgement letter.

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.See h10 manufacture narrative.

• Brand Name: SYRINGE 5ML HEPARIN 100 UNIT
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18993051
• MDR Text Key: 338884784
• Report Number: 1911916-2024-00219
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: (01)30382903064244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 306424
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention