MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 3.3 QT. HINGE CAP WITH PETALS; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: 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: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd sharps collector 3.3 qt.Hinge cap with petals experienced a lid that was difficult to close/would not close.The following information was provided by the initial reporter: according to the customer's report, the lid does not shut.
Event or Problem Description
It was reported that the bd sharps collector 3.3 qt.Hinge cap with petals experienced a lid that was difficult to close/would not close.The following information was provided by the initial reporter: according to the customer's report, the lid does not shut.
Additional Manufacturer Narrative
H.6.Investigation: sample was returned for investigation.The reported problem of a lid that was difficult to close/would not close was not observed with the returned sample.No problems were found.Dhr was performed and no issues related to the complaint were observed.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

• Brand Name: BD SHARPS COLLECTOR 3.3 QT. HINGE CAP WITH PETALS
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11580545
• Report Number: 2243072-2021-00892
• Device Sequence Number: 2955943
• Product Code: FMI
• UDI-Device Identifier: 00382903054886
• UDI-Public: 00382903054886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: Lay User/Patient
• Device Model Number: 305488
• Device Catalogue Number: 305488
• Device Lot Number: 0247002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1