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

Catalog Number 300182

Device Problem Break (1069)

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

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

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 and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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.

Event Description

It was reported that the bd¿ sharps collector had a damaged lid.The following information was provided by the initial reporter, translated from spanish to english: 1 damaged lid.

Manufacturer Narrative

No product was returned by the customer.Photos representation was provided for the complaint.According to the dhr review, during the manufacturing process no issues were reported for damaged or broken lids for the lot number (2061960) 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.Investigation: based on the pictures and information provided by customer, it can be stated the following: the lid is cracked/damaged from one corner.Through the lot number reported, it can be confirmed that this product was manufactured by flex on march 2, 2022.According with this investigation, 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, in can be concluded that products sold out of usa goes through different distribution stages where this kind of issue may be generated due to the 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 damaged.Based on that assessment, it can be confirmed that issue could be generated by several variables like hit, incorrect handling, incorrect storage or non-suitable packaging during partial sells.By other hand the likelihood to send damaged material by flex is very low due to there are several controls to verify this kind of issues.Because of this, additional information is needed about the handling and storage within distributor facility to rule out that this issue was generated by distributors.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, one additional complaint was received through the last twelve months for the same part number and issue.This previous complaint was closed as incomplete since there was not enough evidence provided in order to determine the root cause as related to the manufacturing process.As per the picture sample being received, an investigation could be performed, and a root cause could be determined as 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.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since there is not enough information like method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility.The controls were verified within the manufacturing process and confirmed as capable to detect broken or damaged lids.H3 other text : see h10.

Event Description

It was reported that the bd¿ sharps collector had a damaged lid.The following information was provided by the initial reporter, translated from spanish to english: 1 damaged lid.

• 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 ; 8448235433
• MDR Report Key: 16502871
• MDR Text Key: 310914908
• Report Number: 2243072-2023-00320
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

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: 2061960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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