MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR

Catalog Number 305647

Device Problem Component Missing (2306)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

It was reported that the bd¿ sharps collectors were missing their lids.The following information was provided by the initial reporter: cat# of product being complained: bd305647 description of product: sharps collector 72l ns 5ea/ca lot or s/n: (b)(4) complaint category: fail to function / defective incident date: (b)(6) 2022.

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as flextronics is an oem manufacturing site.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of product received with missing lids could not be verified due to the product not being returned for failure investigation.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number (1256990) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were one issues reported for missing lids for the same part number throughout the last twelve months.Based on information provided it wasn¿t possible to determine the root cause like a failure mode related to the manufacturing process since there was not enough information provided like a picture from original packaging, method used to handle material, shipped partial sells and storage controls of the remaining product within distributors facilities to perform an exhaustive investigation.The current process controls were verified and confirmed as capable to detect missing lids.

Event Description

It was reported that the bd¿ sharps collectors were missing their lids.The following information was provided by the initial reporter: cat# of product being complained: bd305647 description of product: sharps collector 72l ns 5ea/ca.Lot or s/n: (b)(6) complaint category: fail to function / defective incident date: 20 jul 2022.

Manufacturer Narrative

H6: investigation summary: no sample but photo representation was provided by the customer.The customer complaint of product received with missing lids however, based on the pictures provided, it can be seen that slider is missing could be verified with pictures for failure investigation.According to the dhr review process, the result showed there were no issues reported like missing slider during the manufacturing process for the lot number (1256990) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there was no issues reported for the same part number and issue throughout the last twelve months.Investigation: based in the evidence received from customer showing the lack of component (slider) and lot number provided, it¿s acknowledged that this product was manufactured by flex on september 2021 and we are able to confirm this as related to the manufacturing process since this issue had already been identified within the process.Additionally, the current process was reviewed and confirmed that assembly between lid and slider is performed manually and inspected visually per production department and a second inspection based on aql sampling plan is performed by quality department, this process has been confirmed as capable to detect this kind of issues (missing slider), however, omission error within the process could happen.Additionally, a review of customer complaint records was conducted and the results showed that one additional complaint was received during the last twelve months for the same product and issue, for this reason, this problem has been considered an isolated event and no further investigation is required.As part of the containment action, quality alert will be posted in order to aware all the personnel involved in the manufacturing process of this product.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.Conclusion: based on this investigation it was determined that this failure mode is related to the manufacturing process since the lack of slider would be an omission error within the process.The current manufacturing process was reviewed and it was found as capable of detecting missing components such as sliders, however, omission error could happen during visual inspection.Additionally, this is an isolated issue since there was only one additional complaint received for the last twelve months for the same part number and issue.Quality alert was posted within the process in order to make aware all the people involved in the manufacturing process of this product.All the complaint information was also captured 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.

Event Description

It was reported that the bd¿ sharps collectors were missing their lids.The following information was provided by the initial reporter: cat# of product being complained: bd305647 description of product: sharps collector 72l ns 5ea/ca lot or s/n: (b)(6) complaint category: fail to function / defective.Incident date: (b)(6) 2022.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• 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: 15224466
• MDR Text Key: 305068561
• Report Number: 2243072-2022-01338
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

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: 305647
• Device Lot Number: 1256990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/09/2022; 10/03/2022
• Supplement Dates FDA Received: 09/27/2022; 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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