MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	300253
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that "white paint" was found along the base of the bd hypoint¿ hypodermic needle when it was opened.The following information was provided by the initial reporter: "when looking at the needle in the first kit i opened, the needle had some white paint along the base and up the inside of it on one part, so i didn't use this needle and put it aside" "patient reported that indeed that there was some white paint around the base where the needle is attached to the syringe.".
Event or Problem Description
It was reported that "white paint" was found along the base of the bd hypoint¿ hypodermic needle when it was opened.The following information was provided by the initial reporter: "when looking at the needle in the first kit i opened, the needle had some white paint along the base and up the inside of it on one part, so i didn't use this needle and put it aside"."patient reported that indeed that there was some white paint around the base where the needle is attached to the syringe.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD HYPOINT HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11098367
• Report Number: 8041187-2020-00886
• Device Sequence Number: 16352893
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 8226370
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1