MAUDE Adverse Event Report: BECTON DICKINSON BD¿ 64L EXTRA LARGE SHARPS COLLECTOR HINGE TOP WITH GASKET LIQUID ABSORBING PAD; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305609
Medical Device Problem Code	Structural Problem (2506)
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¿ 64l extra large sharps collector hinge top with gasket liquid absorbing pad the lid was incorrectly assembled.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about misassembly of lid of sharps collector.According to the customer's report, the sliding lid was assembled upside down.This issue was found in three products.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.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¿ 64l extra large sharps collector hinge top with gasket liquid absorbing pad the lid was incorrectly assembled.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about misassembly of lid of sharps collector.According to the customer's report, the sliding lid was assembled upside down.This issue was found in three products.
Additional Manufacturer Narrative
H6: investigation summary: according with this investigation, there was not enough information provided like pictures of the nonconformance or a lot number, however within the report, the issue description states that the sliding lid was assembled upside down.With that explanation, we can identify this failure mode (incorrect assembly) as an issue directly related to the manufacturing process due to process omission by the operator.According to the dhr review, during the manufacturing process no issues were reported for incorrect assembly for the part number reported under this complaint.A review of the ncmr¿s was performed; the results exhibit no issues reported for the same part number and issue (incorrect assembly) throughout the last twelve months.Based on this investigation it was determined that this failure mode is related to the manufacturing process since the incorrect assembly between lid and slider would be an omission error within the process.

• Brand Name: BD¿ 64L EXTRA LARGE SHARPS COLLECTOR HINGE TOP WITH GASKET LIQUID ABSORBING PAD
• 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: 15339643
• Report Number: 2243072-2022-01445
• Device Sequence Number: 15168935
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943575
• 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): 09/12/2022

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: 305609
• Device Catalogue Number: 305609
• 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: 09/12/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/26/2022
• 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