MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTIUSE NESTABLE SHARPS COLLECTOR; CONTAINER, SHARPS

Model Number 305456

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

D.4 device expiration date: na.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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.

Event Description

It was reported that 20 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 verbatim report, the shape of the lid of sharps collector 13.2l was different from the usual one.

Manufacturer Narrative

Investigation summary: no sample received but photos representation was provided for the complaint.This is a report about a deformed lid of sharps collector also according to the customer's the shape of the lid of sharps collector 13.2l was different from the usual one was confirmed.A dhr review process was made, and the result showed there were no issues reported like incorrect lid 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, 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, and shipped from flex.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 wrong material sorted 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.Additional information is needed to determine the root cause, since this kind of issue could also be generated due to different variables like incorrect handling or product mixed by distributor at the time to send the product to the end user due to partial sales.As part of the investigation, a review of the customer complaint records was performed and the result showed that there are no additional complaints 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 be performed on basis of photo representation, and a root cause could be determined as potential root cause as below: wrong material sorted.Non-controlled method to ship partial boxes to end user.Incorrect packaging process at the time to perform partial sales.Conclusion: based on the information provided, it was not possible to determine the root cause as a failure mode related to the manufacturing process since there are different variables that could have caused this issue.However, this could potentially be related to the manufacturing process due to wrong sorted material or inappropriate line clearance, for this reason, quality alert was generated to aware all the personnel involved.Information like method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility are required.The controls were verified and confirmed as capable to detect mixed lids.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 20 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 verbatim report, the shape of the lid of sharps collector 13.2l was different from the usual one.

• Brand Name: BD¿ MULTIUSE NESTABLE SHARPS COLLECTOR
• Type of Device: CONTAINER, SHARPS
• 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: 16747006
• MDR Text Key: 313406747
• Report Number: 2243072-2023-00621
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903054565
• UDI-Public: (01)00382903054565
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943134
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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