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

Catalog Number	306424
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 306424, batch #: 329951n.It was reported by customer that the product had no demarcations to indicate dosing.Verbatim: rcc received a complaint via email.Email(s) attached.U.S.Food & drug administration] heparin 100 unit/ml in sealed packaging had no demarcations to indicate dosing.
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.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
Pr (b)(4).Follow up for device evaluation it was reported the product had no demarcations to indicate dosing.To aid in the investigation, one prefilled sample in a sealed packaging flow wrap was received for evaluation by our quality team.A visual inspection was performed, and the syringe barrel label is missing.No other defects or imperfections were observed.This defect could occur if there was a ja during the syringe barrel labeling process.A device history record review was completed for provided material number 306424, lot 329951n.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.Verification of the syringe barrel processes were performed.The settings were correct, and the flow of product was good.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received material #: 306424 batch #: 329951n it was reported by customer that the product had no demarcations to indicate dosing.Verbatim: rcc received a complaint via email.Email(s) attached.U.S.Food & drug administration] heparin 100 unit/ml in sealed packaging had no demarcations to indicate dosing.

• 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: 18968213
• Report Number: 1911916-2024-00212
• Device Sequence Number: 15072776
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: (01)30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 10/31/2025
• Device Catalogue Number: 306424
• Device Lot Number: 329951N
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown