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

Model Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 6 bd sharps coll next gen 5.4qt red 20/pack were missing lids.The following information was provided by the initial reporter: somehow our south location ended up with 6 containers without lids.
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.The date received by manufacturer has been used for this.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: na.
Additional Manufacturer Narrative
H.6.Investigation summary: 6 samples received from the customer for quality investigation.It was reported by the customer that 6 sharps containers were missing lids was confirmed.Further photos representation was provided for the complaint to the supplier and investigation response received from supplier and attached roi and other attachments in investigation overview tab.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number (2019939) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed no issue reported for missing lids for the same part number throughout the last twelve months.Investigation: according with this investigation and evidence provided it can be seen the following: ¿ there are missing lids from the base collectors.¿ from the label, it can be identified the lot number 2019939 and it can be confirmed this product was manufactured on january 19, 2022.¿ the product packaging is not the original.With this information, it¿s concluded that there are many variables that could generate this failure mode since the handling, transportation, storage or partial sales of this product by distributor are unknown.Additional information is required to discard issue was generated by distributor facility, since partial sells and controls to handle remaining material is unknown, therefore, the likelihood of sending boxes with incorrect quantity exist.In addition, the current manufacturing controls were reviewed, and confirmed the capability to detect this type of issue (missing lids).As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, five additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as not manufacturing related/incomplete since there was not enough information provided from customer to determine the root cause.Weight records: the weighing database was evaluated to confirm that every box manufactured under this lot number was package with the correct quantity of lids at the time to perform the packing process.According to review of every record for weighted boxes, it was summarized the following: 1.The lot was built for 9,920 units with a standard pack of 20 units per box, with a total of 496 boxes.There were found acceptable records for every single box manufactured in this lot.2.All the 496 weight records were greater than the lowest validated limit set in the weighing system.Potential root cause: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non-controlled handling within distributor facilities.Based on information provided, it wasn¿t possible to determine the root cause like a failure mode related to the manufacturing process since variables like method used to handle material, shipped partial sells and storage controls of the remaining product within distributors facilities is needed to perform an exhaustive investigation.The current process controls were verified and confirmed as capable to detect missing lids.Additionally, acceptable records were found for each box manufactured of the lot number reported under this customer complaint during the review of the weighing system records (greater than the lowest validated limit under the weighing system).If additional information like a photo of original packaging used can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 6 bd sharps coll next gen 5.4qt red 20/pack were missing lids.The following information was provided by the initial reporter: somehow our south location ended up with 6 containers without lids.

• Brand Name: BD SHARPS COLL NEXT GEN 5.4QT RED 20/PACK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15478544
• Report Number: 2243072-2022-01611
• Device Sequence Number: 5673024
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: 2019939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown