MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305918
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
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.(b)(4).
Event or Problem Description
It was reported that an unspecified number of needle sftygld 18 x 1-1/2 rb experienced leakage at the connection site during use.The following information was provided by the initial reporter: date of incident (yyyy-mm-dd): (b)(6) 2020.Type of incident/problem: malfunction, during or after use.Level of harm: no effect, did not reach patient, detected before use or does not touch person during use.Incident details: solution was drawn up into a syringe, a needle was attached and when the solution was being injected into an iv bag the area around the hub of the needle was leaking.The needle was attached correctly and this problem happened on more than one occasion.Who was affected? no person affected.Unexpected or prolonged care? no.Frequency of problem: recurring.Device information.Device name/description: needle hypodermic safety glide 18 gauge x 1.5 inch manufacturer code/model: 305918.Serial or lot number: 9170953.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/23/2020.H.6.Investigation: two safetyglide needle assemblies and two opened blister packs from batch 9170953 (p/n 305918) were received and evaluated.It was observed visible liquid droplets were present inside the hub.No visual defects were observed on either of the samples received.The potential root cause could not be determined based on the samples received.No visual defects were observed, and the samples were manipulated so leakage testing could not be performed.No corrective actions are required at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.
Event or Problem Description
It was reported that an unspecified number of needle sftygld 18x1-1/2 rb experienced leakage at the connection site during use.The following information was provided by the initial reporter: date of incident (yyyy-mm-dd): 2020 (b)(6).Type of incident/problem: malfunction - during or after use.Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.Incident details: solution was drawn up into a syringe, a needle was attached and when the solution was being injected into an iv bag the area around the hub of the needle was leaking.The needle was attached correctly and this problem happened on more than one occasion.Who was affected? no person affected.Unexpected or prolonged care? no.Frequency of problem: recurring.Device information: device name/description: needle hypodermic safety glide 18 gauge x 1.5 inch.Manufacturer code/model: 305918.Serial or lot number: 9170953.

• Brand Name: NEEDLE SFTYGLD 18X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10339905
• Report Number: 1213809-2020-00492
• Device Sequence Number: 19568644
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: 30382903059189
• 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): 08/19/2020

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: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 9170953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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