MAUDE Adverse Event Report: BECTON DICKINSON BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET

Catalog Number	305604
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2019
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: n/a.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 lid on the bd¿ chemotherapy sharps collector slide top with gasket was installed upside-down.
Event or Problem Description
It was reported that the lid on the bd¿ chemotherapy sharps collector slide top with gasket was installed upside-down.
Additional Manufacturer Narrative
Investigation summary: dhr- according to the dhr review process; the result showed there were no issues reported like lid upside-down during the manufacturing process of the lot number reported under this customer complaint.It can confirm that the slider door was upside-down placed.The affected product belongs to lot number 8177922.Based on this samples the failure mode it was confirmed like issue related to the manufacturing process.Current process controls: a visual inspection is being performed by production department to ensure the correct placement position of slider in the lid, a second inspection based on an aql sampling plan is being performed by quality inspector to ensure this assembly.As part of this investigation it was noted that for other sku¿s a vision system was implemented in the manufacturing station where the lid and the slider door are assembled.This system consists in a camera to detect when the slider is missing or misplaced.Conclusion.Based on this investigation and information provided from customer it was confirmed the root cause like a failure mode related to the manufacturing process.

• Brand Name: BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8302344
• Report Number: 2243072-2019-00155
• Device Sequence Number: 10801786
• Product Code: FMI
• UDI-Device Identifier: 50382903056045
• UDI-Public: 50382903056045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: 305604
• Device Lot Number: 8177922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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