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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1IN BLUNT FILL; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1IN BLUNT FILL; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE Back to Search Results
Catalog Number 305181
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event or Problem Description
It was reported that needle 18x1in blunt fill was coring and there was foreign matter in the syringe.The following information was provided by the initial reporter: material no: 305181, batch no: unknown.It was reported that needles are coring and plastic shards are seen in the medication within the syringe.
 
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Brand Name
NEEDLE 18X1IN BLUNT FILL
Common Device Name
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key11336255
Report Number1911916-2021-00130
Device Sequence Number4568468
Product Code GAA
UDI-Device Identifier00382903051816
UDI-Public00382903051816
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/05/2021
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 Other
Device Catalogue Number305181
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/21/2021
Initial Report FDA Received Date02/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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