MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 18X1-1/2 SB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305199
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that needle shield penetration occurred with a needle 18x1-1/2 sb.The following information was provided by the initial reporter, "needle sticking through cap causing needle stick.".
Additional Manufacturer Narrative
Investigation summary: one (1) sample was received from the customer for investigation.The returned sample was examined visually using unaided vision.The needle has pierced the needle shield and the point is sticking out of the needle shield.The needle shield has a bend to it which caused the needle to pierce through the shield when the needle shield was pressed on.This misassembled part was then packaged automatically and therefore reached the customer.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Conclusion: the needle shield has a bend to it which caused the needle to pierce through the shield when the needle shield was pressed on.This misassembled part was then packaged automatically and therefore reached the customer.
Event or Problem Description
It was reported that needle shield penetration occurred with a needle 18x1-1/2 sb.The following information was provided by the initial reporter, "needle sticking through cap causing needle stick.".

• Brand Name: NEEDLE 18X1-1/2 SB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8693202
• Report Number: 1911916-2019-00581
• Device Sequence Number: 16648535
• Product Code: FMI
• UDI-Device Identifier: 30382903051992
• UDI-Public: 30382903051992
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 305199
• Device Lot Number: 8117703
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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