MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1-1/2 SB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305199
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on 23 april, 2020.Medwatch report # (b)(4) report source other: medwatch report a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that needle 18x1-1/2 sb pulled out of hub.This was discovered during use.The following information was provided by the initial reporter: material no: 305199 batch no: 9269108.It was reported that: needle pulled out of hub.Event description per email states: "obtaining medication pre-procedure, rn attached a pink needle to a syringe and inserted syringe into medication and the needle separated from the pink hub which was cracked and the needle remained in the medication." the medwatch reported was received in (b)(4) on 23-apr-2020 and it reflected in the awareness date.The report was not sent to the (b)(4) until 09/17/2020.
Additional Manufacturer Narrative
H.6.Investigation summary a device history record review was completed by our quality engineer team for provided material number 305199 and lot number 9269108.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
It was reported that needle 18x1-1/2 sb pulled out of hub.This was discovered during use.The following information was provided by the initial reporter: material no: 305199; batch no: 9269108.It was reported that: needle pulled out of hub.Event description per email states: "obtaining medication pre-procedure, rn attached a pink needle to a syringe and inserted syringe into medication and the needle separated from the pink hub which was cracked and the needle remained in the medication." the medwatch reported was received in franklin lakes on 23-apr-2020 and it reflected in the awareness date.The report was not sent to the rcc until 09/17/2020.
Event or Problem Description
It was reported that needle 18x1-1/2 sb pulled out of hub.This was discovered during use.The following information was provided by the initial reporter: material no: 305199; batch no: 9269108.It was reported that: needle pulled out of hub.Event description per email states: "obtaining medication pre-procedure, rn attached a pink needle to a syringe and inserted syringe into medication and the needle separated from the pink hub which was cracked and the needle remained in the medication." the medwatch reported was received in franklin lakes on (b)(6) 2020 and it reflected in the awareness date.The report was not sent to the rcc until (b)(6) 2020.
Additional Manufacturer Narrative
The following fields have been updated with corrections: b.3.Date of event: 2020-09-10.The date received by manufacturer has been used for this field.G.4.Date received by manufacturer: 2020-09-10.

• Brand Name: NEEDLE 18X1-1/2 SB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10564236
• Report Number: 1911916-2020-00883
• Device Sequence Number: 3028742
• Product Code: FMI
• UDI-Device Identifier: 30382903051992
• UDI-Public: 30382903051992
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/07/2020

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 Expiration Date: 10/31/2024
• Device Model Number: 305199
• Device Catalogue Number: 305199
• Device Lot Number: 9269108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 09/10/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/03/2020; 10/07/2020
• 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