MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR HINGE CAP WITH PETALS

Catalog Number	305488
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
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 detached from the bd¿ sharps collector hinge cap with petals during use and the disposed products came out.The following information was provided by the initial reporter, translated from (b)(6) to english: "the lid detached and disposed products came out.".
Additional Manufacturer Narrative
H.6.Investigation: dhr was performed and no ncr's were raised during the production of this lot.All testing was within specification.Picture was reviewed and complaint was confirmed.When base was manufactured and when the operator was assembling the cap to base they did not completely attach it to base.Placed a quality alert at press for next two runs and increased inspections to 100% for the next two runs.After completing two production run for a total of 38,400pcs with 100% inspection there were no detached caps found.
Event or Problem Description
It was reported that the lid detached from the bd¿ sharps collector hinge cap with petals during use and the disposed products came out.The following information was provided by the initial reporter, translated from japanese to english: "the lid detached and disposed products came out.".

• Brand Name: BD SHARPS COLLECTOR HINGE CAP WITH PETALS
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9557794
• Report Number: 2243072-2019-02975
• Device Sequence Number: 2353206
• Product Code: FMI
• UDI-Device Identifier: 50382903054881
• UDI-Public: 50382903054881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• 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): 03/30/2020

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: 305488
• Device Lot Number: 9016002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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