MAUDE Adverse Event Report: BECTON DICKINSON BD¿ EXTRA LARGE SHARP COLLECTOR, RED, 9 GAL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ extra large sharp collector, red, 9 gal there was no clamping mechanism.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305616 batch no: unknown it was reported by the cusotme that they received product where one lid did not have a lock on it.Verbatim: customer received one lid without a lock on it.
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.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.Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd¿ extra large sharp collector, red, 9 gal there was no clamping mechanism.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305616, batch no: unknown.It was reported by the customer that they received product where one lid did not have a lock on it.Verbatim: customer received one lid without a lock on it.
Additional Manufacturer Narrative
Photo representation was provided for the complaint.According to the dhr review, during the manufacturing process no issues were reported for missing component (slider) for the part number reported under this complaint.A review of the ncmr¿s was performed; the results exhibit one issue reported for the same part number and issue throughout the last twelve months.Based on the evidence received from customer showing the lack of component (slider) and with the report description stating that they received product where one lid did not have a lock on it, we can identify this failure mode as an issue directly related to the manufacturing process, since this issue had already been identified within the process.As part of this investigation, it was noted that this product is manufactured in machine bd-12, which already has an improvement action implemented (vision system to detect misplaced or lack of slider) under capa record ca-j1001297.In addition, a review of customer complaint records was performed and according with the cc¿s records, four additional complaints were received through the last twelve months for the same product family and issue.These previous complaints were closed as related to the manufacturing process since there were evidence provided such as lot number and pictures in order to determine the root cause.For this reason, quality alert has been implemented in order to aware all the personnel involved in the manufacturing process of this product.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be done on basis of photo : omission error within the visual inspection.Based on this investigation, it was determined that this issue is related to the manufacturing process since the lack of slider could be caused due to an omission error within the process.This failure mode has been previously detected, for this reason improvement action is already implemented under capa record ca-j1001297 (vision system to detect misplaced or lack of slider) and since there was no lot number provided, it can¿t be confirmed if this product was manufactured before or after the implementation, however the current process controls were verified and confirmed as capable to detect the lack of component (slider).As containment action, a quality alert is already posted within the process in order to make aware all the people involved in the manufacturing process of this product.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.H3 other text : see h10.

• Brand Name: BD¿ EXTRA LARGE SHARP COLLECTOR, RED, 9 GAL
• 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: 15341045
• Report Number: 2243072-2022-01446
• Device Sequence Number: 5133976
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 00382903056163
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 305616
• Device Catalogue Number: 305616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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