MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA 3.0L YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 300450

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 11 sharps coll canada 3.0l yellow were missing lids.The following information was provided by the initial reporter: "we have a box of item no: 010678 bd sharps container yel 3.0l, there are 11 units came without lids.Can you please send us the lids.".

Manufacturer Narrative

H.6.Investigation: the actual product nor photo representation was provided.However, a review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids.A review of non-conforming material report (ncmr) was performed for the last twelve months and no ncmr¿s were reported for missing lids for the same part number.There was one additional complaint recorded for the same part number in the last twelve months for this lot.The lot was confirmed produced after implementation of corrective actions.A weight system that provides a weighted label for each final box before shipment.The weighing system has already been implemented for this product to ensure the correct quantity of pieces per box before shipping.Without the weighted label from the outermost box a root cause cannot be confirmed at this time.The possible root cause was repackaging for partial sales by a distributor.Unfortunately, the original packaging and weighted label is required to identify or confirm this issue.Based on these findings, our investigation is inconclusive.H3 other text : see h.10.

Event Description

It was reported that 11 sharps coll canada 3.0l yellow were missing lids.The following information was provided by the initial reporter: " we have a box of item no: 010678 bd sharps container yel 3.0l, there are 11 units came without lids.Can you please send us the lids.".

• Brand Name: SHARPS COLL CANADA 3.0L YELLOW
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10112348
• MDR Text Key: 199298472
• Report Number: 2243072-2020-00867
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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
• Device Operator: Other
• Device Catalogue Number: 300450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other