MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ SHARPS COLLECTORS

Catalog Number	305435
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing location is (b)(4).This manufacturing location is not registered with the fda.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: unknown.Device manufacture date: unknown.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 3 cases of bd recykleen¿ sharps collectors were found packaged with the "wrong covers" prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other.D.8.Device single use?: no.H.3.Device returned to manufacturer: yes.
Event or Problem Description
It was reported that 3 cases of bd recykleen¿ sharps collectors were found packaged with the "wrong covers" prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
This supplemental is being filed to correct follow up number for mfr report# follow up 2, as well as include investigation.The following fields were updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 22-jun-2018.H.6.Investigation summary: the actual product was returned and pictures were provided for investigation.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported lot was performed for the past 12 months and there was no issue identified during manufacturing that could have caused or contributed to the reported incident.However three additional complaints were received throughout the last twelve months for the same part number for the same issue and due to an elevated occurrence a corrective and preventive action was initiated to reduce or eliminate the occurrences.In conclusion, a second 100% inspection was implemented within the process as part of the containment action.The issue will continue to be evaluated and monitored by bd for any trends.H3 other text : see h.10.
Event or Problem Description
It was reported that 3 cases of bd recykleen¿ sharps collectors were found packaged with the "wrong covers" prior to use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD RECYKLEEN¿ SHARPS COLLECTORS
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7659471
• Report Number: 2243072-2018-00435
• Device Sequence Number: 2501681
• Product Code: FMI
• UDI-Device Identifier: 00382903054350
• UDI-Public: 00382903054350
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305435
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/02/2023; Not provided
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/08/2023; 09/06/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown