MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305165
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a leak while using the bd precisionglide¿ needles.Report 2 of 2.The following was received by the initial reporter: problem: on 2 occasions ((b)(6)), the needle, when mounted on a syringe, leaks on the side of the cannula.There seems to be a small leak.As we're dealing with radioactive products, there's a risk of contamination of work areas, or splashes on a patient or employee.The problematic needles have not been preserved, but we have two samples of the problematic batch.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that there was a leak while using the bd precisionglide¿ needles.Report 2 of 2.The following was received by the intiial reporter: problem: on 2 occasions (mid-july and august 1), the needle, when mounted on a syringe, leaks on the side of the cannula.There seems to be a small leak.As we're dealing with radioactive products, there's a risk of contamination of work areas, or splashes on a patient or employee.The problematic needles have not been preserved, but we have two samples of the problematic batch.
Additional Manufacturer Narrative
Investigation summary: a device history review could not be completed as no batch number was provided.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.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17668846
• Report Number: 1911916-2023-00629
• Device Sequence Number: 7105676
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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 Catalogue Number: 305165
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/28/2023
• 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 Sex: Unknown