MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 1QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305635
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.Date of event: unknown.The date received by manufacturer has been used for this field.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 there was no label on the sharps coll 1qt red.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported that there was no label on the package.".
Additional Manufacturer Narrative
H.6.Investigation: bdj received 5 actual samples and confirmed there was no label on the 5 products.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process of the part number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids issue for the same part number throughout the last twelve months.According with the pictures received was confirmed the lack of label like a failure mode related to the manufacturing process.A review of customer complaint records was performed; in accordance with the cc¿s records, no additional complaints were received throughout the last twelve months for the same part number and issue.Root cause: product label missing on base due to variation on spaces among labels.-there is not defined a specification for this component.Workstation not suitable for to perform reprocessing the bases (labels) -the workstation must be modified for a better reprocessing of the material.H3 other text : see h.10.
Event or Problem Description
It was reported that there was no label on the sharps coll 1qt red.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that there was no label on the package.".

• Brand Name: SHARPS COLL 1QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12277990
• Report Number: 2243072-2021-02022
• Device Sequence Number: 4494835
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 305635
• Device Catalogue Number: 305635
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1