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

Model Number	305921
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
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.
Event or Problem Description
It was reported that during injection leakage occurred from the hub with a bd safetyglide¿ needle.The following information was provided by the initial reporter: when giving a b12 injection the needle leaked from the location of where the safety device attaches to the hub.Withdrew needle from pt and obtained another needle to finish the injection without difficulty.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that during injection leakage occurred from the hub with a bd safetyglide¿ needle.The following information was provided by the initial reporter: when giving a b12 injection the needle leaked from the location of where the safety device attaches to the hub.Withdrew needle from pt and obtained another needle to finish the injection without difficulty.
Additional Manufacturer Narrative
The following fields have been updated with additional information that was provided by customer: b.3.Date of event: (b)(6) 2019.H3 other text : see h.10.
Event or Problem Description
It was reported that during injection leakage occurred from the hub with a bd safetyglide¿ needle.The following information was provided by the initial reporter: when giving a b12 injection the needle leaked from the location of where the safety device attaches to the hub.Withdrew needle from pt and obtained another needle to finish the injection without difficulty.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation? yes.D.10.Returned to manufacturer on:(b)(6)2020.H.6.Investigation: one safetyglide needle assembly in an opened blister pack from batch 9028720 (p/n 305921) was received and evaluated.The sample appeared to be manipulated as there was dried red fluid droplets present on the inside and outside of the hub.The sample was visually inspected under 10x magnification with no visual defects observed.The reported defect was not identified in the samples received.Physical unused samples form the same batch are necessary for leakage testing.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.
Event or Problem Description
It was reported that during injection leakage occurred from the hub with a bd safetyglide¿ needle.The following information was provided by the initial reporter: when giving a b12 injection the needle leaked from the location of where the safety device attaches to the hub.Withdrew needle from pt and obtained another needle to finish the injection without difficulty.

• 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: 9403619
• Report Number: 1213809-2019-01204
• Device Sequence Number: 11443372
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 01/31/2024
• Device Model Number: 305921
• Device Catalogue Number: 305921
• Device Lot Number: 9028720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 11/15/2019; 10/19/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/09/2019; 12/31/2019; 11/19/2020
• 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