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

Catalog Number	305176
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: medical device expiration date: unknown.H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4: device manufacture date: unknown.
Event or Problem Description
It was reported that the bd precisionglide¿ needle pulled out of the hub when trying to cap and remove it during chemo preparation.The following information was provided by the initial reporter: "our technician was using the yellow needle (bd 305176) to prepare a chemo.When they tried to cap and remove needle from syringe the needle came off.We did not save the needle due to chemo contamination.It was reported that the white rubber where the metal needle and yellow plastic meet may not be properly sealed due to bubbles.Did you experience any adverse events as a result of the reported failure? no; was any medication used with the product? if yes, what was the medication? methotrexate; was treatment able to be completed for the patient? yes.".
Event or Problem Description
It was reported that the bd precisionglide¿ needle pulled out of the hub when trying to cap and remove it during chemo preparation.The following information was provided by the initial reporter: "our technician was using the yellow needle (bd 305176) to prepare a chemo.When they tried to cap and remove needle from syringe the needle came off.We did not save the needle due to chemo contamination.It was reported that the white rubber where the metal needle and yellow plastic meet may not be properly sealed due to bubbles.Did you experience any adverse events as a result of the reported failure? no.Was any medication used with the product? if yes, what was the medication? methotrexate.Was treatment able to be completed for the patient? yes.".
Additional Manufacturer Narrative
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.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16904536
• Report Number: 1911916-2023-00287
• Device Sequence Number: 5359611
• Product Code: FMI
• UDI-Device Identifier: 00382903051762
• UDI-Public: 00382903051762
• 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): 05/16/2023

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: Other
• Device Catalogue Number: 305176
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/31/2023
• 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