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

Model Number 305487

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As nipro, mx is an oem manufacturing site.D.4.Medical device expiration date: na.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with bd sharps collector the lid would not close.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the lid of sharps collector did not close.When using sharps collector, the lid did not close and spontaneously opened after a few seconds.

Manufacturer Narrative

H6: investigation summary the customer reported that the lid of sharps collector did not close.When using sharps collector, the lid did not close and spontaneously opened after a few seconds could not be verified as issue could not be verified.According to the device history record review process, the result showed there were no issues reported as temporary lid not remaining shut during the manufacturing process of the lot number (2267916) reported under this customer complaint.A review of the non-conformance material report was performed; the result showed that no temporary lid issues were reported for the same part number throughout the last twelve months within our process.Investigation: according with investigation and evidence provided, customer reported that the lid of sharps collector did not close.When using the sharps collector, the lid did not close and spontaneously opened after a few seconds.However, bdj received an actual used sample and confirmed that the lid was put in closed position and observed for 1 hour, during this period of time the lid did not open and no abnormality was observed.Additionally, this is a known issue received from japan where from previous complaints investigations, it was found that the temporary closure characteristic it¿s not being evaluated during the inspection process performed by quality since there is not a requirement as part of customer specification, it means that there is no functional test established to the temporary closure feature, nevertheless in order to discard a malfunction on this sku, an engineering study was performed due to the negative trending reported from japan to evaluate functionality on temporary closure, obtaining the following: after 24 hours, none of the tested lids went open by themselves.All the tested parts require a minimum force greater than 1.5lbf to disengage the temporary closure.All the material met the expected results.Furthermore, we have previously received a video as evidence from another customer complaint (cc (b)(4)) from the same region, where it can be seen that collector exceeds the limit indicated on the lid (fill line), which could be reason to generate this kind of issue because at the time to exceed the capacity, they could be causing deformation to the collector.In addition, as part of the manufacturing process, the product includes an ifu (instruction for use) in each box which explain that fill line limit must be not exceeded.However, if the method established within the ifu is not followed as intended then it will not function correctly.Because of this, the storage and handling process method will be needed to determine the root cause since the product could have experienced deformations from an incorrect storage (damaged product).Because of all the information and test presented, we can determine that the failure mode is not related to the manufacturing process.Due to no sample being received, an investigation could be performed on basis of photo representation, and a root cause could be determined as potential root cause as below: potential root cause 1.End user misuse (the end user didn¿t follow the steps stated in the bd sharps collector ifu).2.Incorrect handling, use, storage, transportation issues or inappropriate environment could cause deformation.3.Re-use (if the product is being re-used after an autoclaving process, it will generate deformations).4.Mold issue (improvement opportunity on the design, current molded parts meet drawing specification).Conclusion: based on the result of this investigation, this is not failure mode related to the manufacturing process because the issue reported is a functional test not required by customer specification, therefore neither is evaluated within the process inspections, however, as part of this investigation and due several complaints received, an engineering study was performed to evaluate the functionality of this feature (temporary closure), the results of this es was that the events reported by the customer are not present or were not able to be replicated under controlled test for the existing production parts, therefore, it can be concluded with 95% reliability / 95% confidentiality that the parts producing doesn¿t open by themselves and its required to be applying a force minimum of 1.5lbsf to be opened.Additionally, sample is needed in order to determine the root cause of this 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.

Event Description

It was reported that during use with bd sharps collector the lid would not close.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the lid of sharps collector did not close.When using sharps collector, the lid did not close and spontaneously opened after a few seconds.

• Brand Name: BD SHARPS COLLECTOR
• Type of Device: 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: 17174935
• MDR Text Key: 317636886
• Report Number: 2243072-2023-01076
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305487
• Device Catalogue Number: 305487
• Device Lot Number: 2267916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1