MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305443
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of sharps coll side entry 5.4qt red experienced an incorrectly positioned label with the label being placed too high.Product defect noted during use.The following information was provided by the initial reporter: material no: 305443, batch no: 8037925.Per customer email: the sharps container is # 305443.I'm a clinical operations manager.We just had an osha walkthrough and one of the first things he noticed in all of our exam rooms was that the label on the sharps container (indicating the fill line) has been incorrectly placed on all of our sharp-containers.They have been placed too high, as they should indicate approximately 3/4 full which is the standard.
Event or Problem Description
It was reported that an unspecified number of sharps coll side entry 5.4qt red experienced an incorrectly positioned label with the label being placed too high.Product defect noted during use.The following information was provided by the initial reporter: material no: 305443; batch no: 8037925.Per customer email: the sharps container is #305443.I am a clinical operations manager.We just had an osha walkthrough and one of the first things he noticed in all of our exam rooms was that the label on the sharps container (indicating the fill line) has been incorrectly placed on all of our sharp-containers.They have been placed too high, as they should indicate approximately 3/4 full which is the standard.
Additional Manufacturer Narrative
H.6.Investigation: a product image was provided and the label position was evaluated.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported lot was performed for the past 12 months and there was no issue identified during manufacturing for any labeling concern.The pictures provided indicates that the position of the label is aligned with current specification.In conclusion, a corrective action was not required since the label was visually verified to be in the correct position.The root cause was an incorrect interpretation of product design (the capacity of the product is taken after product is assembled with base and lid).H3 other text : see h.10.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8748636
• Report Number: 2243072-2019-01290
• Device Sequence Number: 19403305
• Product Code: FMI
• UDI-Device Identifier: 50382903054430
• UDI-Public: 50382903054430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 305443
• Device Lot Number: 8037925
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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