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

Catalog Number	306424
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 306424 batch number#: 411432n verbatim#: i'm an inpatient pharmacist for xx.Our facility uses bs posiflush heparin lock flush syringes in all three concentrations (3 units/3 ml, 30 units/3 ml, 300 units/3 ml).On (b)(6) 2024, two 5ml syringes of the 100 units/ml concentration were discovered in one of our medication cabinets.Our staff inspected the rest of the hospital, but these two syringes were the only ones not 3ml.Both 5ml syringes have lot no.411432n and expire 2026-03-31.Most, if not all, of our 100units/ml boxes have an exp.Date of 2026-05-31.Because no other 5ml syringes were discovered, i believe these may have been accidentally packaged in one of the 30-count boxes of 300 units/3ml syringes.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
(b)(4).Follow up it was reported two 5ml syringes of the 100 units/ml concentration may have been accidentally packaged in one of the 30-count boxes of 300 units/3ml syringes.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two 306424 5ml units in their packaging flow wraps.No other information could be obtained from the photo.A device history record review was completed for provided material number 306424, lot 411432n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
Additional information received no patient harm, injury, complication or negative outcome that occurred as a result of the event.

• 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 MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20832327
• Report Number: 1911916-2024-00865
• Device Sequence Number: 4058770
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: (01)30382903064244(11)240423(17)260331(10)411432N
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/26/2024

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: 03/31/2026
• Device Catalogue Number: 306424
• Device Lot Number: 411432N
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown