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

Model Number	305900
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one photo was received and evaluated.Even though event description describes a magellan needle, the photo depicts a bd safetyglide needle package, confirmed to be from batch #9316337 (p/n 305900).Only the package¿s top web is visible.From this vantage point an unshielded needle¿s cannula can be seen sticking out of the side of the package between the top and bottom webs.Since the bottom web view was not presented, no other observations can be made about the sample.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.Investigation conclusion: 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.Root cause description: potential root cause for the double needle and missing shield defects are associated with the packaging process.Machine upgrades have been made to reduce cannulas with missing shields from being packaged.Rationale: capa not necessary.
Event or Problem Description
It was reported that needle sftygld 22x1-1/2 rb came with an extra needle that was sticking out of the package.This was discovered before use.The following information was provided by the initial reporter: material no.: 305900 batch no.: 9316337.It was reported that the customer had a safety needle that had an extra unprotected needle in the package and it was sticking out the side of the package.Nobody was hurt.

• Brand Name: 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
• MDR Report Key: 9975221
• Report Number: 1213809-2020-00252
• Device Sequence Number: 3699973
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 03/31/2020

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: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 9316337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/17/2020
• 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