MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 5ML HEPARIN 10 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event states (b)(6) 2019 (no day is entered on the original document).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that syringe 5 ml heparin 10 unit leaked fluid which splashed into the nurses eye during use.The following information was provided by the initial reporter: material no: 306414 batch no: unknown.It was reported that while injecting heparin from prefilled syringe into the patient's line during a blood drawing procedure fluid from the syringe splashed back into the nurses eye.Verbatim: while injecting heparin from prefilled syringe into the patient's line during a blood drawing procedure fluid from the syringe splashed back into the nurses eye.Patient is on oncology unit, but not other drugs of therapies could have contributed at the time of the event.Injection of heparin into line during blood draw to prevent clotting.
Event or Problem Description
It was reported that syringe 5ml heparin 10 unit leaked fluid which splashed into the nurses eye during use.The following information was provided by the initial reporter: material no: 306414 batch no: unknown it was reported that while injecting heparin from prefilled syringe into the patient's line during a blood drawing procedure fluid from the syringe splashed back into the nurses eye.Verbatim: while injecting heparin from prefilled syringe into the patient's line during a blood drawing procedure fluid from the syringe splashed back into the nurses eye.Patient is on oncology unit, but not other drugs of therapies could have contributed at the time of the event.Injection of heparin into line during blood draw to prevent clotting.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

• Brand Name: SYRINGE 5ML 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: 9191928
• Report Number: 1911916-2019-01089
• Device Sequence Number: 3107687
• Product Code: NZW
• UDI-Device Identifier: 30382903064145
• UDI-Public: 30382903064145
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 306414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• 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