MAUDE Adverse Event Report: BECTON DICKINSON BD WALLMATE¿ COLLECTOR STARTER KIT PEARL BASE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305550
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.B3.Date of event is unknown; awareness date has been used for this field.H3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd wallmate¿ collector starter kit pearl base the latch was broken.There was no report of patient impact.The following information was provided by the initial reporter: customer provided the attached document for some customer returns as defective i need to return for credit.Customer requested to issue ra¿s.Lot # material# po# comment 2213956 305550 21733822 latch is broken.
Event or Problem Description
It was reported while using bd wallmate¿ collector starter kit pearl base the latch was broken.There was no report of patient impact.The following information was provided by the initial reporter: customer provided the attached document for some customer returns as defective i need to return for credit.Customer requested to issue ra¿s.Lot #, material#, po#, comment, 2213956.305550.21733822.Latch is broken.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 19jul2023 h6: investigation summary actual sample received from customer for investigation and verified and photo representation was provided for the complaint to the supplier.According to the device history record review, during the manufacturing process no issues were reported for damaged or broken lids for the lot number reported under this complaint (2213956).A review of the ncmr¿s was performed; the results exhibit no issue reported for the same part number and issue throughout the last twelve months.Investigation according with this investigation and with evidence received, it can be noticed that product is cracked/damaged and within customer complaint report it¿s mentioned that latch of product was broken.Based on the lot number provided (2213956), we are able to confirm that this product was manufactured by flex on august 1, 2022.The variables that could generate this failure mode such as hit, incorrect handling, transportation, incorrect storage or non-suitable packaging during partial sells are unknown, for this reason, additional information is required to discard issue was generated by a distributor facility, since partial sells and controls to handle remaining material is unknown.In addition, the current manufacturing controls were reviewed, and confirmed the capability to detect this type of issue (broken / damaged parts).As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, one additional complaint was received through the last twelve months for the same part number and issue.This previous complaint was closed as non-manufacturing related since there was not enough information provided from customer.As per the sample being received, an investigation could be performed, and a root cause could be determined as potential root cause: ¿ non-controlled method to ship partial boxes to end user (re-packaging process).¿ product damaged during the shipment or distribution.¿ not suitable packaging.¿ transportation damages.Conclusion: based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to repackage, shipped partial sells using inadequate packaging and controls to storage the remaining product within distributor facility.The controls were verified within the manufacturing process and confirmed as capable to detect lid damaged.If additional information like a photo of packaging used 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.H3 other text : see h.10.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: sharp collectors.Device failure: locks defective.
Event or Problem Description
No additional information.

• Brand Name: BD WALLMATE¿ COLLECTOR STARTER KIT PEARL BASE
• 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 ; 8448235433
• MDR Report Key: 17213399
• Report Number: 2243072-2023-01133
• Device Sequence Number: 15196001
• Product Code: FMI
• UDI-Device Identifier: 50382903055505
• UDI-Public: (01)50382903055505
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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: 305550
• Device Catalogue Number: 305550
• Device Lot Number: 2213956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/24/2023; Not provided
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/11/2023; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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