MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 27X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305921
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that needle sftygld 27x5/8 rb safety mechanism was broken.This was discovered after use.The following information was provided by the initial reporter: material no: 305921 batch no: 0002401.It was reported that: rn removed syringe from package, revealed no safety shield on/for needle.Event description per email states: rn administered subcutaneous injection at patient bedside.Rn went to activate the safety needle device and was unable to do so as part of the safety device was missing/broken.Rn searched patients bedding and floor for missing piece.Rn did not hear/feel anything break or fall to floor.Rn stated "i think it's just missing a piece." rn also stated she "gave the injection before i noticed a piece was missing." safety closure device broken and unable to activate the safety mechanism.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10.Device available for eval?: yes.D10.Returned to manufacturer on: 7/7/2020.H6.Investigation: two photos and two safetyglide needle assemblies were received and evaluated.One was in a fully sealed blister pack from batch 0002401 (p/n 305921) and one was loose inside a plastic container.It was observed through the container, the loose needle assembly was missing the bottom half of the safety shield, which was rejectable per product specification.Potential root cause for the missing safety shield defect is associated with the needle manufacturing process.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the epoxy to fix it; after that, a plastic safety mechanism is assembled, at the end the plastic shield is assembled to the part.In this case, the safety mechanism was not properly assembled.No corrective actions are necessary based on the defective rate identified.Batch 0002401 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
Event or Problem Description
It was reported that needle sftygld 27x5/8 rb safety mechanism was broken.This was discovered after use.The following information was provided by the initial reporter: material no: 305921 batch no: 0002401.It was reported that: rn removed syringe from package, revealed no safety shield on/for needle.Event description per email states: rn administered subcutaneous injection at patient bedside.Rn went to do activate the safety needle device and was unable to do so as part of the safety device was missing/broken.Rn searched patients bedding and floor for missing piece.Rn did not hear/feel anything break or fall to floor.Rn stated "i think it's just missing a piece".Rn also stated she "gave the injection before i noticed a piece was missing." safety closure device broken and unable to activate the safety mechanism.

• Brand Name: NEEDLE SFTYGLD 27X5/8 RB
• 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: 10209906
• Report Number: 1213809-2020-00426
• Device Sequence Number: 16701332
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 12/31/2024
• Device Model Number: 305921
• Device Catalogue Number: 305921
• Device Lot Number: 0002401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other