MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 3.3QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305488
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The manufacturing location for this product is oem - premium plastic solution (pps).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 3.3qt red lid came off.The following information was provided by the initial reporter: this is a report about detachment of the lid of sharps collector.According to the customer's report, the hcp disposed of a needle and lifted the product, and the lid then came off and needles were scattered.
Additional Manufacturer Narrative
H.6.Investigation: dhr was performed.No ncr's were raised during the production of this lot.All testing was within specification.The complaint could not be confirmed and the root cause is undetermined.Samples were not returned for investigation.H3 other text : see h.10.
Event or Problem Description
It was reported that sharps coll 3.3qt red lid came off.The following information was provided by the initial reporter: this is a report about detachment of the lid of sharps collector.According to the customer's report, the hcp disposed of a needle and lifted the product, and the lid then came off and needles were scattered.

• Brand Name: SHARPS COLL 3.3QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12271801
• Report Number: 2243072-2021-02015
• Device Sequence Number: 19890058
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 305488
• Device Catalogue Number: 305488
• Device Lot Number: 0304002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1