MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305058
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
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 recykleen¿ sharps collector was broken.The following information was provided by the initial reporter: "bd recykleen sharp collector broken.".
Event or Problem Description
It was reported that the bd recykleen¿ sharps collector was broken.The following information was provided by the initial reporter: "bd recykleen sharp collector broken.".
Additional Manufacturer Narrative
H6: investigation summary: the customer provided photos with the complaint of broken sharps collectors.The photos showed clear evidence of cracks and the customer's complaint has been verified.This information was then sent to the supplier for further investigation.According to the dhr review process, the result showed there were no issues reported like lids broken or cracked during the manufacturing process of the lot number (1057912).A review of the ncmr¿s was performed; the result showed there were no issues reported like broken or damage issue for the same part number (305517) throughout the last twelve months ((b)(6) 2020 thru (b)(6) 2021).With the information provided, the root cause was not established but possible root causes include: 1non-controlled method to ship partial boxes to end user (re-packaging process).2non controlled handling within distributor facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see h10.

• Brand Name: BD RECYKLEEN¿ 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12422304
• Report Number: 2243072-2021-02231
• Device Sequence Number: 19879242
• Product Code: FMI
• UDI-Device Identifier: 50382903050586
• UDI-Public: 50382903050586
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 305058
• Device Catalogue Number: 305058
• Device Lot Number: 0087913
• 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: 08/06/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2020
• 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