MAUDE Adverse Event Report: BECTON DICKINSON BD¿ CLEAR COUNTERBALANCED DOOR, 5.4 QT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305551
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
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.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.Device expiration date: unknown.
Event or Problem Description
It was reported that the bd¿ clear counterbalanced door, 5.4 qt experienced the lids missing.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.
Additional Manufacturer Narrative
H6: investigation summary: 17 samples received by the customer and investigation performed , samples received without the lids and complaints could be verified.Photos representation provided to the supplier as evidence.According to the dhr review, during the manufacturing process no issues were reported for missing lids for the lot 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 throughout the last twelve months.Based on the pictures and information provided from the samples received in vh location, it can be mentioned the following: products arrived without their lids.Lot number 2104950 was manufactured by flex on april 14, 2022.Products are not in their original box and packaging configuration.According with this investigation, the variables that could generate this failure mode such as handling, transportation, storage or partial sales from distributor are unknown.Additional information is required to discard that issue was generated by distributor, since partial sells and controls to handle remaining material are 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, no additional complaints were received through the last twelve months for the same part number and issue.
Event or Problem Description
It was reported that the bd¿ clear counterbalanced door, 5.4 qt experienced the lids missing.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.

• Brand Name: BD¿ CLEAR COUNTERBALANCED DOOR, 5.4 QT
• 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: 15341161
• Report Number: 2243072-2022-01447
• Device Sequence Number: 5037440
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/07/2022

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: 305551
• Device Catalogue Number: 305551
• Device Lot Number: 2104950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• 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: 09/07/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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