MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 17GAL YELLOW; SHARPS CONTAINER

Catalog Number	305614
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: an invalid lot # was provided as 8234808.If a valid lot # is provided the record will be updated.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).Oem manufacture: 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.
Event or Problem Description
It was reported that 6 sharps coll chemo 17gal yellow experienced a missing lid/slide lid/clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 305614 batch no.: 8234808.6 collectors arrived at the customer without lids.
Event or Problem Description
It was reported that 6 sharps coll chemo 17gal yellow experienced a missing lid/slide lid/clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 305614 batch no.: 8234808 6 collectors arrived at the customer without lids.
Additional Manufacturer Narrative
H.6.Investigation: the actual product nor photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The root cause is unknown.The issue most likely occurred during fulfillment when repackaged for distribution.This complaint may have occurred from partial sales sold by a distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.H3 other text : see h.10.

• Brand Name: SHARPS COLL CHEMO 17GAL YELLOW
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10188118
• Report Number: 2243072-2020-00946
• Device Sequence Number: 2405173
• Product Code: MMK
• UDI-Device Identifier: 50382903056144
• UDI-Public: 50382903056144
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (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): 07/15/2020

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: 305614
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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