MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305551
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.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 was reported that sharps coll next gen 5.4qt clear 20/pack was damaged.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported that the sharps collector was missing lower parts that will fall into damage product.  verbatim: missing lower parts will fall in damage product.
Event or Problem Description
It was reported that sharps coll next gen 5.4qt clear 20/pack was damaged.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported that the sharps collector was missing lower parts that will fall into damage product.  verbatim: missing lower parts will fall in damage product.
Additional Manufacturer Narrative
H6: investigation summary: the customer complained that missing lower parts will fall in damage product.No photos or samples were received to verify this.The dhr review was not performed due to the lot number was not provided by customer.A review of the ncmr¿s was performed; the result showed that on last 12 months no ncmrs has been opened for short shot for the same part number.Root cause is unknown without any information or sample to investigate.H3 other text : see h10.

• Brand Name: SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11971615
• Report Number: 2243072-2021-01657
• Device Sequence Number: 4269597
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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 Model Number: 305551
• Device Catalogue Number: 305551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1