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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no: 306413 batch no: unknown.It was reported that before use of the syringe 3ml heparin 10 unit the syringe has incorrect data related to latex in the fda gudid database.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.The following information was provided by the initial reporter: event description per attached email states, "the posiflush syringe has incorrect data related to latex.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.
Event or Problem Description
Material no: 306413; batch no: unknown.It was reported that before use of the syringe 3ml heparin 10 unit the syringe has incorrect data related to latex in the fda gudid database.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.The following information was provided by the initial reporter: event description per attached email states, "the posiflush syringe has incorrect data related to latex.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.
Additional Manufacturer Narrative
H.6.Investigation: one photo was provided for evaluation.It shows the shelf box drawing.Highlighting: this product is not made with natural rubber latex or preservatives.This packaging is in accordance with our drawing and specifications.This complaint has been reported to our posiflush platform.A device history record review could not be completed as no batch number was provided.H3 other text : see h.10.

• 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: 9194434
• Report Number: 1911916-2019-01093
• Device Sequence Number: 11334461
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 306413
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other