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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the lid was difficult to fit onto the sharps coll next gen 5.4qt clear 20/pack.The following information was provided by the initial reporter: "the lid of item # 305551 is not fitting into the wall bracket on item # 305447.".
Event or Problem Description
It was reported that the lid was difficult to fit onto the sharps coll next gen 5.4qt clear 20/pack.The following information was provided by the initial reporter: "the lid of item # 305551 is not fitting into the wall bracket on item # 305447.".
Additional Manufacturer Narrative
H6: investigation summary : the customer complained about difficulty of assembly with 305551 sharps container however no photos or samples were received for investigation.Without further information, the complaint cannot be verified and the root cause remains unknown.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 there were no issues reported like assembly difficult for the same part number throughout the last twelve months.Potential root causes include: 1.Customer misuse.2.Incorrect lid.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.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: 12014149
• Report Number: 2243072-2021-01690
• Device Sequence Number: 14309087
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: other,user facility
• 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: 05/19/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/16/2021
• 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