MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305551
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the sharps coll next gen 5.4qt clear 20/pack experienced a missing lid or slide lid/clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.305551 batch no.0027918.Reported issue: missing lid.
Event or Problem Description
It was reported that the sharps coll next gen 5.4qt clear 20 / pack experienced a missing lid or slide lid / clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.305551, batch no.0027918.Reported issue: missing lid.
Additional Manufacturer Narrative
H.6.Investigation: it was reported lids missing.A sample and photo representation was not provided for evaluation.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids for the reported lot number.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance for the same part number.This lot was confirmed produced after corrective actions.A weight system that provides a weighted label for each final box before shipment has already been implemented for this product to ensure the correct quantity of pieces per box before shipping.It was not possible to confirm that any failure mode was related to the manufacturing process with the information provided.There appears to have been a repackaging issue which occurred during distribution by the distributor, ¿medline¿.The actual root cause is unknown.Distributor control procedures to process and repackage containers and lids is unknown.Based on these findings, our investigation is inconclusive.

• Brand Name: SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10433996
• Report Number: 2243072-2020-01289
• Device Sequence Number: 2714158
• Product Code: FMI
• UDI-Device Identifier: 50382903055512
• UDI-Public: 50382903055512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/02/2020

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: 305551
• Device Lot Number: 0027918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other