MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 1QT; 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	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd sharps collector 1qt had missing label information.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the label was not affixed properly and was wrinkled onto two products.
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd sharps collector 1qt had missing label information.The following information was provided by the initial reporter, translated from (b)(6) to english: according to the customer's report, the label was not affixed properly and was wrinkled onto two products.
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd sharps collector 1qt had missing label information.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the label was not affixed properly and was wrinkled onto two products.
Additional Manufacturer Narrative
H.6.Investigation: according to the dhr review process, the result showed there were no issues reported like product with damaged label during the manufacturing process of the lot number (1102905) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like product with label damaged issue for the same part number (305635) throughout the last twelve months ((b)(6) 2021 thru (b)(6) 2022).As part of this investigation, with the pictures and issue description provided from customer (¿label was not sticked properly and was wrinkled onto two products¿), it can confirm the failure mode reported (labeling concerns) as related to the manufacturing process, also with evidence provided it was possible to confirm the following: the label design belongs to an 1qt family of product (305635).The lot number (1102905) belongs to 1qt product.According with this investigation this is a failure mode related to manufacturing process since this failure mode could be generated during the automatic placement performed by the pneumatic applicator installed in the printer machine and omitted by the operator during the inspection.For this reason, quality alert was implemented to help on prevention of the wrong placing of labels during the labeling process through the conveyor.Also, as part of the investigation a review of customer complaint records was performed according with the cc¿s records, no complaints were received through the last twelve months for the same part number and issue.H3 other text : see h.10.

• Brand Name: BD SHARPS COLLECTOR 1QT
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13170879
• Report Number: 2243072-2021-03037
• Device Sequence Number: 14647613
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 1102905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown