MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 1QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305635
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 bd sharps coll 1qt red had no lid.The following information was provided by the initial reporter, translated from japanese to english: the customer report that in a carton that should contain 60 products there were only 59 lids with one missing.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received.Additional attempts to get more information were made, however in none of the cases additional information was retrieved.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 (1345941) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were one issues reported for missing lids for the same part number throughout the last twelve months.According with this investigation and lot number provided, this product was manufactured by flex on (b)(6)2021, however, there is not enough information provided from customer like pictures of original packaging in order to determine the root cause.For this reason, it can be concluded that there are many variables that could generate this failure mode due to unknown handling and transportation, if the material is stored or if there are partial sales.Additional information is needed about the handling and storage within distributor facility to rule out that this issue was generated by distributors, because the distributors can do partial sells and the controls to handle remaining material is unknown, therefore, the likelihood that they send boxes with incorrect quantity could happen.In addition, the current manufacturing controls were reviewed, and they were confirmed as capable to detect this kind of issues (missing lid).As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, nine additional complaints were received through the last twelve months for the same part number and issue.
Event or Problem Description
It was reported that 1 bd sharps coll 1qt red had no lid.The following information was provided by the initial reporter, translated from japanese to english: the customer report that in a carton that should contain 60 products there were only 59 lids with one missing.

• Brand Name: BD SHARPS COLL 1QT RED
• 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: 15021767
• Report Number: 2243072-2022-00945
• Device Sequence Number: 11354861
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• 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): 08/02/2022

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: 305635
• Device Catalogue Number: 305635
• Device Lot Number: 1345941
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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