MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD PRECISIONGLIDE¿ INTRADERMAL BEVEL NEEDLE; HYPODERMIC SINGLE LUMEN

Catalog Number	305110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufactured date is unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Medical device expiration date is unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.
Event or Problem Description
It was reported that during use the bd luer-lok¿ 1-ml syringe needle broke off.The following information was provided by the initial reporter: "material#: 305110, batch#: unknown.It was reported by customer that the needle broke off.Verbatim: lot: unk: externalref: (b)(4): caller reported the needle broke off.".

• Brand Name: BD PRECISIONGLIDE¿ INTRADERMAL BEVEL NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14620099
• Report Number: 1911916-2022-00288
• Device Sequence Number: 4347114
• Product Code: FMI
• UDI-Device Identifier: 00382903051106
• UDI-Public: 00382903051106
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K874414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/11/2022

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 Number: 305110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 19 YR
• Patient Sex: Female