MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTIUSE NESTABLE SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305456
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ multiuse nestable sharps collector lid was deformed.The following information was provided by the initial reporter: this is a report about a deformed lid of sharps collector.According to the customer's report the shape of the lid of sharps collector was different from the usual one.
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 the bd¿ multiuse nestable sharps collector lid was deformed.The following information was provided by the initial reporter: this is a report about a deformed lid of sharps collector.According to the customer's report the shape of the lid of sharps collector was different from the usual one.
Additional Manufacturer Narrative
H6: investigation summary no samples or pictures were received as evidence from the customer.A device history record review process was made, and the result showed there were no issues reported like incorrect lids during the manufacturing process of the lot number reported (2307958) under this complaint.A review of the ncmr¿s was performed; the result showed that non-conformances were reported for the same part number and issue throughout the last twelve months.Investigation: based on this investigation and previous complaint cc-jrz-00001597 (pr (b)(4)), with the information and evidence provided by the customer, it is reported that sharps container #305456 was received with the wrong cap (model 8363110), stating that the lid was different from the usual one.With the lot number provided 2307958, we are able to confirm that this product was manufactured by flex on november 11, 2022.The correct cap corresponded to this part number (8018326) was built under the lot number 2300951 and manufactured on october 27, 2022.Meanwhile, the subassembly received by customer was manufactured two weeks apart.However, this issue could potentially be related to the manufacturing process since both subassemblies are being manufactured in the same machine, for this reason, there could have been an inappropriate line clearance or incorrect material assortment to the finish good machine when configuration / model was requested to change, for this reason, quality alert was posted to aware all the personnel involved in the manufacturing process of this products to reinforce visual inspection and also, feedback was also provided on the correct assortment of material.As part of the investigation, a review of the customer complaint records was performed and the result showed that there is one additional complaint reported for the same issue and part number throughout the last twelve months, being this considered 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: ¿ wrong material assortment.Containment action ¿ quality alert was posted to aware all the personnel involved in the manufacturing process of this product.Corrective actions ¿ personnel was retrained regarding correct assortment of material to prevent escapes of wrong/mixed pieces.Conclusion based on the information provided, it was possible to determine the root cause as a failure mode related to the manufacturing process due to wrong assortment of material.The current manufacturing process was reviewed and it was found as capable of detecting mixed material, however, omission error could happen, for this reason, quality alert was posted within the process in order to make aware all the people involved in the manufacturing process of this product and personnel was retrained regarding material assortment.H3 other text : see h10.
Additional Manufacturer Narrative
A code updated to a02 as the issue was for mixed/product lot.The customer thought there was something deformed but they received the wrong product.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: sharps collectors.Device failure: mixed product / lots.
Event or Problem Description
No additional information.

• Brand Name: BD¿ MULTIUSE NESTABLE 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16959276
• Report Number: 2243072-2023-00819
• Device Sequence Number: 5452617
• Product Code: FMI
• UDI-Device Identifier: 00382903054565
• UDI-Public: (01)00382903054565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 305456
• Device Catalogue Number: 305456
• Device Lot Number: 2307958
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 05/29/2025
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/15/2023; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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