MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 19GA 1IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305186
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.: 305186, batch no.: unknown.It was reported that before use of the needle 19ga 1in tw the needle was sticking through the cap prior to opening the package.The following information was provided by the initial reporter: the needles was sticking through the cap prior to opening the package.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
Material no.: 305186 batch no.: unknown.It was reported that before use of the needle 19ga 1in tw the needle was sticking through the cap prior to opening the package.The following information was provided by the initial reporter: the needles was sticking through the cap prior to opening the package.

• Brand Name: NEEDLE 19GA 1IN TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9178491
• Report Number: 1911916-2019-01072
• Device Sequence Number: 11314955
• Product Code: FMI
• UDI-Device Identifier: 30382903051862
• UDI-Public: 30382903051862
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 10/23/2019

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: 305186
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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