MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL CHEMO 19GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the bd¿ sharps coll chemo 19gal yellow has been found experiencing inability for the lid to close before use.The following has been provided by the initial reporter: material no: 305613 batch no: unknown.It was reported that the bin will not close all the way on the trolley.The customer ordered a chemo sharps collector and foot trolley and stated the foot trolley is not operating properly, it does not allow the bin to close all the way.
Additional Manufacturer Narrative
H.6.Investigation: it was reported that the bin will not close all the way on the trolley.The customer below ordered a chemo sharps collector and foot trolley and stated the foot trolley is not operating properly, it does not allow the bin to close all the way.A sample and pictures were provided for evaluation.A review of the device history record (dhr) and non-conforming material report (ncmr) was performed for the last twelve months there were no issues reported like trolley defective during the manufacturing process.It was confirmed the arm of trolley isn¿t properly placed due to the drilled hole on the arm that was misplaced.The root cause was incorrect placement during drilling.This was a manufacturing issue and an update to the manufacturing process instruction has been completed to prevent the issue from occurring again.H3 other text : see h.10.
Event or Problem Description
It has been reported that the bd¿ sharps coll chemo 19gal yellow has been found experiencing inability for the lid to close before use.The following has been provided by the initial reporter: material no: 305613.Batch no: unknown.It was reported that the bin will not close all the way on the trolley.The customer ordered a chemo sharps collector and foot trolley and stated the foot trolley is not operating properly, it does not allow the bin to close all the way.

• Brand Name: BD¿ SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9438042
• Report Number: 2243072-2019-02756
• Device Sequence Number: 14173590
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 02/12/2020

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 Catalogue Number: 305613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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