MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305918
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the safety mechanism on the bd safetyglide¿ needle broke.The following information was provided by the initial reporter: "one of our nurses reported a broken needle.".
Additional Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 0238974 all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 0238974 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.One photo of a loose safetyglide needle assembly next to an opened blister pack from batch 0238974 (p/n 305918) was received and evaluated.It was observed the safety mechanism was broken and the cannula was exposed, which was rejectable per product specification.Potential root cause for broken safety mechanism defect is associated with the needle supplier¿s manufacturing process.The photos were forwarded to the needle supplier for further evaluation and investigation.Probable root cause for this defect is that when the safety mechanism was assembled the fixture holding the part was not properly centered inducing a damage to the safety mechanism.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported that the safety mechanism on the bd safetyglide¿ needle broke.The following information was provided by the initial reporter: "one of our nurses reported a broken needle.".

• Brand Name: BD SAFETYGLIDE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11115068
• Report Number: 1213809-2020-00944
• Device Sequence Number: 3698412
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: 30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 0238974
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1