MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
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 (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.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt red lid does not stay closed.This occurred on 6 occasions.The following information was provided by the initial reporter: material no.: 305443 batch no.: 0357920.It was reported the lids do not stay closed well and the tops pop open.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt red lid does not stay closed.This occurred on 6 occasions.The following information was provided by the initial reporter: material no.: 305443 batch no.: 0357920.It was reported the lids do not stay closed well and the tops pop open.
Additional Manufacturer Narrative
H6: investigation summary two samples were received and tested by our quality team and then sent to the supplier facility.The lids were functionally tested and no issue was realized.The lids locked in place and when sealed could not be reopened.This is proper function and the lids were shown to be correct with the lot mentioned.According to the dhr review process, the result showed there were no issues reported like lid will not shut/ lid broken during the manufacturing process of the lot 0357920 reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid will not shut/lid broken issue for the same part number throughout the last twelve months.Without further information like a sample that can be tested and proven defective, the root cause remains unknown.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 SIDE ENTRY 5.4QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11860011
• Report Number: 2243072-2021-01513
• Device Sequence Number: 3962295
• Product Code: FMI
• UDI-Device Identifier: 00382903054435
• UDI-Public: 00382903054435
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/31/2021

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: 305443
• Device Catalogue Number: 305443
• Device Lot Number: 0357920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1