MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER

Catalog Number	305160
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
Event or Problem Description
It was reported that unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
Additional Manufacturer Narrative
H6: investigation summary: the customer provided 12 samples with the complaint of broken lids.The sharps containers were received without any lids so the complaint was investigated by the supplier as it was received.According to the dhr review process, the result showed there were no issues reported like lid broken/damaged during the manufacturing process of the lot number 0303954 reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken/damaged for the same part number throughout the last twelve months.The supplier investigated this complaint as a missing lids issue due to what was received and were unable to determine root cause.H3 other text : see h10.

• Brand Name: UNSPECIFIED BD SHARPS CONTAINER
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11963342
• Report Number: 2243072-2021-01638
• Device Sequence Number: 19176100
• Product Code: MMK
• UDI-Device Identifier: 00382903051601
• UDI-Public: 00382903051601
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K112774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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 Catalogue Number: 305160
• Device Lot Number: 0303954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1