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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 305155
Medical Device Problem Code Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.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 there was no expiration date listed on the needle 22x1 rb box.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: pharmacist stated, boxes don't have an expiration date.
 
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Brand Name
NEEDLE 22X1 RB
Common Device Name
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key11346359
Report Number1911916-2021-00141
Device Sequence Number4997805
Product Code FMI
UDI-Device Identifier30382903051558
UDI-Public30382903051558
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K021475
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 02/09/2021
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 Health Professional
Device Model Number305155
Device Catalogue Number305155
Device Lot Number9022940
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2021
Initial Report FDA Received Date02/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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