MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE 3ML HEPARIN 10 UNIT; HEPARIN FLUSH

Catalog Number	306413
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6), usa has been used as a default.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.
Event or Problem Description
It was reported that multiple times, the plunger of a bd¿ syringe 3ml heparin 10 unit will ¿come out¿ while drawing up medication.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: a sample was not available for evaluation by a quality engineer.Since, there was not a sample available for evaluation, an investigation could not be performed and bd was not able to verify the reported issue.Dhr/bhr review.There were no documented issues for the complaint of batch 711169n during this production run.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.Capa not required for this event.

• Brand Name: BD¿ SYRINGE 3ML HEPARIN 10 UNIT
• Common Device Name: HEPARIN FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7268220
• Report Number: 1911916-2018-00062
• Device Sequence Number: 1801739
• 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: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 306413
• Device Lot Number: 711169N
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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