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

Model Number	305443
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 5 sharps coll side entry 5.4qt red were missing their lids.The following information was provided by the initial reporter: "customer stated lids were missing.No damage and not opened box.".
Additional Manufacturer Narrative
H6: investigation summary the actual product nor photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The root cause is unknown.The issue most likely occurred during fulfillment when repackaged for distribution.This complaint may have occurred from partial sales sold by a distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.An omission error was also possible by the manufacturer and a quality alert has been posted for the manufacturing line for this process.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.Bd will continue to monitor for any trends.
Event or Problem Description
It was reported that 5 sharps coll side entry 5.4qt red were missing their lids.The following information was provided by the initial reporter: "customer stated lids were missing.No damage and not opened box.".

• 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: 11102093
• Report Number: 2243072-2020-02256
• Device Sequence Number: 14398143
• Product Code: FMI
• UDI-Device Identifier: 00382903054435
• UDI-Public: 00382903054435
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (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): 01/13/2021

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: 0121918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1