MAUDE Adverse Event Report: BECTON DICKINSON BD YELLOW NON-VENTED SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 300196

Device Problem Crack (1135)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).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 3 bd yellow non-vented sharps collectors experienced device damage while still considered operable.The following information was provided by the initial reporter: cracked sharp box lid for 22.7l.

Event Description

It was reported that 3 bd yellow non-vented sharps collectors experienced device damage while still considered operable.The following information was provided by the initial reporter: cracked sharp box lid for 22.7l.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of cracked sharp box lid for 22.7l could not be verified due to the product not being returned for failure investigation.According to the device history record review, during the manufacturing process no issues were reported for damaged or broken lids for the lot number (2108931) 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.According with this investigation, there is not enough information provided from customer like a picture of the damaged product to determine the root cause of this non-conformance, however it was noticed that this issue arose from a product sold in asia pacific and all the shipping and transportation process for that country 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 the handling carried out during the transportation and those activities are out of flex¿s reach.Considering that failure mode is related to broken/damaged 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, non-suitable packaging during partial sells.As part of this investigation, a review of customer complaint records was performed; according to the customer complaint records, no additional complaints were received through the last twelve months for the same part number and issue.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD YELLOW NON-VENTED SHARPS COLLECTOR
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16075086
• MDR Text Key: 306833299
• Report Number: 2243072-2022-02245
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 01/06/2023

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: 300196
• Device Lot Number: 2108931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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