MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ HYPODERMIC NEEDLE

Model Number	300255
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle pierced through the shield.This was discovered before use.The following information was provided by the initial reporter: a hospital reported that a nurse found a defect with recormon pfs.The nurse opened the blister and found the needle passed through the unopened needle container.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9634678
• Report Number: 8041187-2020-00016
• Device Sequence Number: 654129
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9071970
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/07/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown