MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 6.9QT RED VENTED CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305489
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is premium plastic solutions.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: 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.
Event or Problem Description
It was reported that 5 sharps coll 6.9qt red vented cap were received without labels.The following information was provided by the initial reporter: "received all 5/ea containers with no labels".
Additional Manufacturer Narrative
H6: investigation summary: the customer provided a photo with evidence of no label on sharps container.This verified the complaint of missing/ damaged label.Due to no sample or lot number being provided, the investigation is limited as to where exactly the failure occurred.A device history record review for the last 6 months was performed and there were no issues raised with this material.Root cause is unknown as to where the failure occurred.H3 other text : see h10.
Event or Problem Description
It was reported that 5 sharps coll 6.9qt red vented cap were received without labels.The following information was provided by the initial reporter: "received all 5/ea containers with no labels.".

• Brand Name: SHARPS COLL 6.9QT RED VENTED CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11712732
• Report Number: 2243072-2021-01229
• Device Sequence Number: 4253956
• Product Code: FMI
• UDI-Device Identifier: 00382903054893
• UDI-Public: 00382903054893
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/17/2021

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 Model Number: 305489
• Device Catalogue Number: 305489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1