MAUDE Adverse Event Report: BECTON DICKINSON BD® PHLEBOTOMY SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305635
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4 device expiration date: na the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.H3.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® phlebotomy sharps collector label was missing.The following information was provided by the initial reporter: this is a report about label dislodgment.It was unknown if the product label was incorrectly attached or melted due to high temperature, but the label was dislodged.
Event or Problem Description
It was reported that 2 bd® phlebotomy sharps collector label was missing.The following information was provided by the initial reporter: this is a report about label dislodgment.It was unknown if the product label was incorrectly attached or melted due to high temperature, but the label was dislodged.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or pictures were received as evidence.Customer confirmed there was no more additional information available.According to the dhr review, during the manufacturing process no issues like label dislodgement were reported for the lot number reported under this complaint (b)(4).A review of the ncmr¿s was performed; the results exhibit no issues reported for the same part number and issue throughout the last twelve months.Investigation: as part of this investigation, there is not enough evidence like a picture showing the issue described under this complaint, however, with lot number provided we are able to confirm that this product was manufactured by flex on february 24, 2023 and within customer complaint report, it¿s mentioned that it was unknown if the product label was incorrectly attached or melted due to high temperature, but the label was dislodged.To identify the root cause, additional information is required since it is needed to see if this material was not relabeled by third parties and confirm if it refers to the product label placed within our process, as well as identify the condition of the label in order to rule out that the problem could have been generated during the storage of the product (humidity conditions that could have affected).Also, as part of the investigation, a review of customer complaint records was performed and according with the cc¿s records, no complaints were received through the last twelve months for the same part number and matter, for this reason this is an isolated issue.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: incorrect placing of the label.Omission error within the visual inspection.Incorrect repackaging at the time to perform partial sales.Inappropriate handling within distributor facilities.Conclusion: based on the information provided, it was not possible to confirm this problem as related to the manufacturing process since there was not enough information provided in order to understand completely the described condition of the label, for this reason, additional information like physical sample or picture of the product label is needed to determine if the root cause is from our process.The controls were verified within the manufacturing process and confirmed as capable to detect the reported failure mode.No additional complaints have been received for the same part number and issue, being this considered an isolated issue.If additional information that helps to find the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD® PHLEBOTOMY SHARPS COLLECTOR
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17597663
• Report Number: 2243072-2023-01485
• Device Sequence Number: 7364908
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: (01)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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2023

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 Catalogue Number: 305635
• Device Lot Number: 3055921
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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