MAUDE Adverse Event Report: BECTON DICKINSON BD CLEAR 5.4QT SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305551
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).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.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 the bd clear 5.4qt sharps collector experienced device damage while still considered operable.The following information was provided by the initial reporter the product was damaged/cracked.
Event or Problem Description
It was reported that the bd clear 5.4qt sharps collector experienced device damage while still considered operable.The following information was provided by the initial reporterl the product was damaged/cracked.
Additional Manufacturer Narrative
H.6.Investigation: pictures were received as evidence from the customer in order to proceed with the investigation.According to the dhr review process, the result showed there were no issues reported like broken/damaged bases or labeling concerns during the manufacturing process of the lot numbers reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like broken / damaged bases or labeling concerns for the same part number throughout the last twelve months.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 them, since the distributors can do partial sells, the controls to handle remaining material is unknown.In addition, the current manufacturing controls were reviewed, and they were confirmed as capable to detect this kind of issues (base broken / damaged).Therefore, this nonconformance it can¿t be confirmed as a failure mode related to a manufacturing process.

• Brand Name: BD CLEAR 5.4QT SHARPS COLLECTOR
• 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: 13226487
• Report Number: 2243072-2021-03088
• Device Sequence Number: 3957894
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 1063907
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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