MAUDE Adverse Event Report: BECTON DICKINSON BD CHEMO ONE-PIECE SHARPS COLLECTOR WITH PLUG CAP; SHARPS DISPOSAL

Catalog Number	305493
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
Event or Problem Description
It was reported that the bd chemo one-piece sharps collector with plug cap was removed from a new box and had a puncture on the bottom.No reports of serious injuy or medical intervention noted.
Event or Problem Description
It was reported that the bd chemo one-piece sharps collector with plug cap was removed from a new box and had a puncture on the bottom.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: sample was unavailable, but photos were received for evaluation.Per supplier investigation, after reviewing all device history papers, in house stock with no issues found and photo received from customer it is believed that the collector was damaged during shipping.In addition, all 5 gallon collectors are checked by qc or shift supervisor prior to box being taped shut and placed on slip sheet.This is believed to be a shipping issue; damaged in transit.At this time supplier capa cannot be completed because of findings from investigation, however all personnel were made aware of the complaint and are looking for any similar issues during next run of production.

• Brand Name: BD CHEMO ONE-PIECE SHARPS COLLECTOR WITH PLUG CAP
• Common Device Name: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7531631
• Report Number: 2243072-2018-00318
• Device Sequence Number: 1775704
• Product Code: FMI
• UDI-Device Identifier: 00382903054930
• UDI-Public: 00382903054930
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 305493
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other