MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR

Catalog Number 367216

Device Problem Component Missing (2306)

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

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.Device evaluated by mfr: 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 16 bd¿ sharps collectors had no lids.The following information was provided by the initial reporter: "customer received a case of 367216 sharps collector (our po# 497895) they have complained that the case was missing 16 lids.".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer for investigation.It was reported by the customer that they received a case of sharps collectors, and there were 16 lids missing 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 as missing lids for the lot number: (2301917) reported under this complaint.A review of the non confirming material report review was performed; the results exhibit no issues reported for the same part number and issue throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since information such as method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility is unknown.The controls were verified within the manufacturing process and confirmed as capable to detect the reported failure mode (missing lids).

Event Description

It was reported that 16 bd¿ sharps collectors had no lids.The following information was provided by the initial reporter: "customer received a case of 367216 sharps collector (our po#: (b)(4) they have complained that the case was missing 16 lids.".

• 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: 16199629
• MDR Text Key: 307815937
• Report Number: 2243072-2023-00034
• 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
• Report Date: 02/06/2023

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: 367216
• Device Lot Number: 2301917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1