MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML HEPARIN 10 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306413
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material#:306413, batch#: 417935n, 411439n.It was reported by customer that the defect found in 2 heparin 30 units/3ml syringes discovered this morning.Rcc received a complaint via email.I want to report a defect found in 2 heparin 30 units/3ml syringes discovered this morning (10/17)- please see attached image.Product name and/or catalog number: heparin flush 30 unit/3ml syringe.Lot number or serial number: syringe on left: ndc (b)(4) exp 2025-12-31, lot: 417935n.Syringe on right: (b)(4), exp 2025-10-31, lot: 411439n.Any injuries and/or harm? no.What is the issue you experienced? syringe on the left has the label in the incorrect position.Syringe on the right has the incorrect volume.
Event or Problem Description
No additional information received material #:306413, batch#:417935n, 411439n.It was reported by customer that the defect found in 2 heparin 30units/3ml syringes discovered this morning.Verbatim: rcc received a complaint via email.I want to report a defect found in 2 heparin 30units/3ml syringes discovered this morning (10/17).Product name and/or catalog number: heparin flush 30 unit/3ml syringe lot number or serial number: syringe on left: ndc (b)(4) exp 2025-12-31 lot 417935n syringe on right: (b)(4) exp 2025-10-31 lot 411439n any injuries and/or harm? no.What is the issue you experienced? syringe on the left has the label in the incorrect position.Syringe on the right has the incorrect volume.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there were defects found in two heparin syringes.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two prefilled syringes with no packaging flow wraps.One syringe has the barrel places about 1ml up and the other syringe has the plunger rod-rubber stopper down to the 1ml mark of the scale.No other information could be obtained from the photo.The misplaced label could occur if there was jam during the syringe barrel labeling process.The incorrect fill could occur if there was a jam during the syringe barrel filling process.A device history record review was completed for provided material number 306413, lots 417935n and 411439n.The review revealed there were no quality issues reported during the production of these lots.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the syringe barrel labeler and filler processes were performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 3ML HEPARIN 10 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: 20495723
• Report Number: 1911916-2024-00748
• Device Sequence Number: 14496789
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: (01)30382903064138(11)240627(17)251231(10)417935N
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/22/2024

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: 12/31/2025
• Device Catalogue Number: 306413
• Device Lot Number: 417935N
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown