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

Catalog Number	306424
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacteremia (4846)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Event or Problem Description
Customer response on march 27, 2024.1.Can you please provide an exact date of event? we don¿t have an exact date.Patient reported to us on (b)(6) 2024 they had a rare infection in her port, leclercia adecarboxylata.This has previously been associated with contaminated heparin.Patient believed infection / initial exposure happened ~ 9 weeks ago.I was asked to reach out to bd to see if there had been any other reports of this infection recently.2.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.3.Was there any medical intervention required? entire port removed; tx with vanc/zosyn; sent home on levaquin.4.What was the patient outcome from the infection? could you please provide further description.Entire port removed; tx with vanc/zosyn; sent home on levaquin.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for additional information received.B5: additional information provided.Annex f: codes updated.

• Brand Name: SYRINGE 5ML HEPARIN 100 UNIT
• Common Device Name: 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
• Report Number: 1911916-2024-00219
• Device Sequence Number: 14215809
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: (01)30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• 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,Followup
• Report Date (Section B): 03/29/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 306424
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown