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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
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 that safety cover broke at hinge when safety activated with a bd safetyglide¿ needle.This occurred on 2 separate occasions during use; however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that the plastic hinged cover broke at the hinge when the safety was activated.Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: which facility did it occur at? (b)(6).Lot number or serial number if available ¿ lot # 9323614.Did it only occur once? nurse who reported this event said it happened once before.Did it result in any needlestick injury? no.Do you have the sample to send in for investigation? no.The nurse stated it happened once before ¿ did she provide you with a date of occurrence for the other time it happened or was that date unknown? answer: unfortunately the nurse didn¿t state the date of occurrence so i believe it was unknown.
Event or Problem Description
It was reported that safety cover broke at hinge when safety activated with a bd safetyglide¿ needle.This occurred on 2 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that the plastic hinged cover broke at the hinge when the safety was activated.Additionally, on 2020-01-10 the bd sales consultant provided the following additional information: which facility did it occur at? (b)(4).Lot number or serial number if available ¿ lot # 9323614.Did it only occur once? nurse who reported this event said it happened once before.Did it result in any needlestick injury? no.Do you have the sample to send in for investigation? no.The nurse stated it happened once before ¿ did she provide you with a date of occurrence for the other time it happened or was that date unknown? answer: unfortunately the nurse didn¿t state the date of occurrence so i believe it was unknown.
Additional Manufacturer Narrative
H.6.Investigation summary one photo was received and evaluated.The photo depicted a loose unshielded safetyglide needle.The safety shield appeared to be partially extended and broken at the connection with the tip cover of the shield.The tip cover was not extended over the tip of the cannula, which was still exposed, indicating the failure occurred before the safety shield was able to get fully extended.No damage or other defects could be discerned from the photo provided.Potential root cause for the broken safety shield is likely associated with the needle manufacturing process.The photo was forwarded to the needle manufacturing plant for further investigation.No corrective actions are necessary for the needle packaging site based on the defective rate identified.Batch 9323614 is considered in compliance with our product specification requirements.One photo was provided.The photo shows a needle assembly with the safety mechanism damaged.Root cause_ safetyglide assembly line.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, then at the end the plastic shield is assembled to the part.In this case, the safety mechanism was not properly assembled inducing the symptom reported.Root cause_ safetyglide assembly line.No actions are to be taken.This is the first complaint to this lot for this defect and any other defect.Inspections and in-process verifications pass.Quality levels are according to our acceptance criteria.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 9643089
• Report Number: 1213809-2020-00026
• Device Sequence Number: 14056450
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: 30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 9323614
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/13/2020
• 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