MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 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 Patient Involvement (2645)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6) has been used as a default.(b)(4).Investigation summary: a device history record review was completed for provided material number 306413 and lot number 022362n.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, thirteen samples were received in their sealed packaging flow wrap for evaluation by our quality team.A visual inspection was performed with no damage or other imperfections observed and the barcode was verified with the scanner.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Rationale: there are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
It was reported that syringe 3ml heparin 10 unit was missing label information.This occurred on 100 occasions.The following information was provided by the initial reporter: material no.: 306413, batch no.: 022362n.It was reported that the barcode on the syringes are cut off and cannot be scanned.

• Brand Name: SYRINGE 3ML HEPARIN 10 UNIT
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11152747
• Report Number: 1911916-2021-00017
• Device Sequence Number: 17173110
• Product Code: NZW
• UDI-Device Identifier: 00382903064137
• UDI-Public: 00382903064137
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 306413
• Device Lot Number: 022362N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1