MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd needle sftygld 22x1-1/2 rb, the user identified the needle pulling loose from the hub.There are no reports of medical intervention.The following information was provided by the initial reporter.The customer stated: it was reported needle separated/broken the needle came away from the syringe and remained in the patient after medication was administered.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 20-apr-2022.H.6.Investigation: one sample and one photo of a safetyglide needle (p/n 305900) batch 7300870 were received and evaluated.The sample has the cannula separated from the hub with a small dot of clear glue-like substance observed on the cannula near the cannula should be attached to the hub.The condition observed is non-conforming per product specifications.The sample was sent to the needle manufacturing site for further evaluation and investigation.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Potential root cause for cannula pulled out defect is associated with assembly line.It is possible that misfeeding of the cannulator may have induced that not enough epoxy was applied.Verification of the cannulator was performed.The settings were correct and the flow of products was good.A device history record review was completed for provided lot number 7300870.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd needle sftygld 22x1-1/2 rb, the user identified the needle pulling loose from the hub.There are no reports of medical intervention.The following information was provided by the initial reporter.The customer stated: it was reported needle separated/broken.The needle came away from the syringe and remained in the patient after medication was administered.

• Brand Name: BD NEEDLE SFTYGLD 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13878250
• Report Number: 1213809-2022-00156
• Device Sequence Number: 20157527
• Product Code: FMI
• UDI-Device Identifier: 00382903059003
• UDI-Public: 00382903059003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• 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): 05/26/2022

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 305900
• Device Lot Number: 7300870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2017
• 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