MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR

Model Number	305635
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
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.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.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 the bd¿ sharps collector was missing a lid.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: "one lid is missing.".
Event or Problem Description
It was reported that the bd¿ sharps collector was missing a lid.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: "one lid is missing.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received.The 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 of the lot number (1082902) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids for the same part number throughout the last twelve months.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD¿ SHARPS COLLECTOR
• Common Device Name: SHARPS COLLECTOR
• 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: 13233217
• Report Number: 2243072-2021-03107
• Device Sequence Number: 19971986
• 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: Foreign,Health Professional,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: Health Professional
• Device Model Number: 305635
• Device Catalogue Number: 305635
• Device Lot Number: 1082902
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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