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

Catalog Number 300182

Device Problem Component Missing (2306)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It was reported that the bd¿ sharps collector was received without the cap.The following information was provided by the initial reporter, translated from spanish to english: they received a device without the cap.

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary photo representation was provided for the complaint.According to the dhr review process, the result showed there were no issues reported as missing lids during the manufacturing process for the lot number reported (1303936).A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids for the same part number throughout the last twelve months.According with this investigation and evidence provided it can be seen the following: the cap of the sharps collector lid is missing.With the lot number 1303936, it can be confirmed this product was manufactured on 10/30/2021.Customer describes they received the sharps collector without the cap.From the picture, it can be seen a white label that is not placed within our manufacturing process.Under this evidence, we can determine this issue as manufacturing related since this type of problem could be caused by operator omission during the assembly between the cap and lid.As part of this investigation, a review of customer complaint records was performed for this part number; according with the cc¿s records, there is no additional records received in the last twelve months reporting this issue, for this reason, this problem has been considered an isolated issue and no further investigation is required.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: omission error within the visual inspection.Containment action :quality alert was posted to aware all the personnel involved in the lid manufacturing process.Based on this investigation, it was determined that this failure mode is related to the manufacturing process since the lack of cap would be an omission error within the process.The current manufacturing process was reviewed and it was found as capable of detecting missing components, however, omission error could happen during visual inspection.Additionally, this is an isolated issue since there was no additional complaints received for the last twelve months for the same part number and issue.

Event Description

It was reported that the bd¿ sharps collector was received without the cap.The following information was provided by the initial reporter, translated from spanish to english: they received a device without the cap.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS CONTAINER
• 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 ; 8015296192
• MDR Report Key: 15218669
• MDR Text Key: 305158833
• Report Number: 2243072-2022-01333
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• 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: 08/30/2022

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
• Device Operator: Other
• Device Catalogue Number: 300182
• Device Lot Number: 1303936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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