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

Catalog Number 300195

Device Problem Component Missing (2306)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.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 no lid.The following information was provided by the initial reporter: "container,contaminated sharp,13l without lid".

Manufacturer Narrative

Investigation summary: photo representation was provided for the complaint of container, contaminated sharp,13l without lid.According to the dhr review process, the result showed there were no issues reported as missing component (cap) during the manufacturing process for the lot number reported (1336944).A review of the ncmr¿s was performed; the result showed there were no issues reported like missing component (cap) for the same part number throughout the last twelve months.According with this investigation and evidence provided it can be seen the following: the cap of the sharp¿s collector lid is missing.With the lot number 1336944, it can be confirmed this product was manufactured on 12/02/2021.Customer describes they received the sharps collector without the cap.Under this evidence, we can determine this issue as manufacturing related since this type of problem could be caused by operator omission during the assembly between the cap and lid.Based on this investigation, it was determined that this failure mode is related to the manufacturing process since the lack of cap would be an omission error within the process.

Event Description

It was reported that the bd¿ sharps collector had no lid.The following information was provided by the initial reporter: "container, contaminated sharp, 13l without 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 ; 8015296192
• MDR Report Key: 15397091
• MDR Text Key: 305998207
• Report Number: 2243072-2022-01485
• Device Sequence Number: 1
• Product Code: MMK
• 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: 09/16/2022

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: 300195
• Device Lot Number: 1336944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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