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

Catalog Number 300740

Device Problem Break (1069)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that 1 bd¿ sharps collector each from lots 1255960, 7124925, and 243939, as well as 3 units from lot 8134935, and 4 units from lot 118912 arrived with damaged lids that couldn't be used.The following information was provided by the initial reporter: product arrived with damaged lid and unable to use the sharps container across multiple batches and different time points.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1255960.Medical device expiration date: na.Device manufacture date: 01-oct-2021.Medical device lot #: 7124925.Medical device expiration date: na.Device manufacture date: 30-may-2017.Medical device lot #: 243939.Medical device expiration date: na.Device manufacture date: 15-sep-2020.Medical device lot #: 8134935.Medical device expiration date: na.Device manufacture date: 21-may-2018.Medical device lot #: 118912.Medical device expiration date: na.Device manufacture date: 11-may-2020.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 1 bd¿ sharps collector each from lots 1255960, 7124925, and 243939, as well as 3 units from lot 8134935, and 4 units from lot 118912 arrived with damaged lids that couldn't be used.The following information was provided by the initial reporter: "product arrived with damaged lid and unable to use the sharps container across multiple batches and different time points.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 18-oct-2022.H6: investigation summary: 4 samples were returned for quality investigation by the customer.1 product arrived with damaged lid and 3 samples received without lid.Additionally, within the reports, customer mentions that product arrived with damaged lids and that was unable to use the sharps container across multiple batches and different time points complaint issue verified.According to the device history record review, during the manufacturing process no issues were reported for damaged or broken lids for the lot numbers reported under this complaint.A review of the ncmr¿s was performed; the results exhibit no issue reported for the same part number and issue throughout the last twelve months.Based on the pictures and information provided by customer, it can be stated the following: several lids are cracked from different angles.Through the lot numbers reported, it can be confirmed that these products were manufactured by flex during the last five years.From the 4 samples received in vernon hills, one sample had broken lid and the rest of them came without it.Additionally, within the reports, customer mentions that product arrived with damaged lids and that was unable to use the sharps container across multiple batches and different time points.According with this investigation, it was noticed that this issue arose from a product sold in australia and all the shipping and transportation process for asia pacific products indicates that flex is in charge of manufacturing, packaging and loading of the product, while bd is in control of transportation, transshipment, distribution and final delivery.For this reason, it can be concluded that products sold out of usa goes through different distribution stages where this kind of issue may be generated due to handling carried out during the transportation and those activities are out of flex¿s reach.Considering that failure mode is related to broken parts, the mold was verified to rule out that the issue could be generated by a damaged on the mold, the assessment confirms that mold was free of damages.Based on that assessment, it can be confirmed that the issue could be generated by several variables like hit, incorrect handling, incorrect storage, or non-suitable packaging during partial sells.As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, no previous additional complaints were received through the last twelve months for the same part numbers and issue.Potential root cause: product damaged during the transshipped process made by bd¿s second provider.Non-controlled method to ship partial boxes to end user.Product damaged during the shipment or distribution.Incorrect repackaging at the time to perform partial sales.

• 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: 15535289
• MDR Text Key: 306606258
• Report Number: 2243072-2022-01715
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903007400
• UDI-Public: (01)00382903007400
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/18/2022

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: 300740
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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