MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 6GAL RED SMALL OPEN CAP; SHARPS CONTAINER

Catalog Number	305160
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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 6gal red small open cap lid was broken.The following information was provided by the initial reporter: the customer reported that the sc lid was broken on arrival.
Event or Problem Description
It was reported that sharps coll 6gal red small open cap lid was broken.The following information was provided by the initial reporter: the customer reported that the sc lid was broken on arrival.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received.Additional attempt to get more information was made, however, the customer confirmed that no additional information was available.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 lid broken for the same part number throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to repackage, shipped partial sells using inadequate packaging and controls to storage the remaining product within distributor facility.H3 other text : see h.10.

• Brand Name: SHARPS COLL 6GAL RED SMALL OPEN CAP
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11611399
• Report Number: 2243072-2021-00936
• Device Sequence Number: 11578965
• Product Code: MMK
• UDI-Device Identifier: 00382903051601
• UDI-Public: 00382903051601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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 Catalogue Number: 305160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1