MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305425
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 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 side entry 5.4qt pearl 12/pk lids do not fit.The following information was provided by the initial reporter: material no: 305425, batch no: unknown.It was reported the lids do not fit the containers.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt pearl 12/pk lids do not fit.The following information was provided by the initial reporter: material no: 305425 batch no: unknown.It was reported the lids do not fit the containers.
Additional Manufacturer Narrative
H.6.Investigation: no photo or sample representation was provided for the complaint.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 incorrect lids issue for the same part number throughout the last twelve months.According with this investigation no lot number, sample and/or pictures of original packaging were provided from the customer regarding the issue reported under this complaint, however, it was noticed that this product was sold by a distributor (henry schein).For this reason, evidence of the packaging used will be needed to determine the root cause.Therefore, due to lack of evidence it can¿t be confirmed this nonconformance as a failure mode related to a manufacturing process, because this kind of issues could be generated due to different variables like incorrect handling, transportation or product mixed (end user also noticed that an incorrect sharp collector was sent to them) by distributor at the time to send the product to the end user.Additional information is needed about the handling and storage within distributor facility to rule out that this issue was generated by distributors.Root cause is unknown.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11593755
• Report Number: 2243072-2021-00906
• Device Sequence Number: 14330327
• Product Code: FMI
• UDI-Device Identifier: 00382903054251
• UDI-Public: 00382903054251
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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: distributor,other
• 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: 305425
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/30/2021
• 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