MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN; SHARPS CONTAINER

Catalog Number 305093

Device Problem Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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 (b)(4) has been listed in and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that sharps coll troly foot-op 19gl recykleen was damaged.The following information was provided by the initial reporter: material no: 305093 , batch no: 9044928.  it was reported that sharps bin 72l slide is not functioning properly with the trolley xl mechanism.

Event Description

It was reported that sharps coll troly foot-op 19gl recykleen was damaged.The following information was provided by the initial reporter: material no: 305093.Batch no: 9044928.  it was reported that sharps bin 72l slide is not functioning properly with the trolley xl mechanism.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-12.H6: investigation summary: a sample representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like trolley defective during the manufacturing process of the lot number 9044928.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for trolley defective for the same part number.According to this investigation, this is a known failure mode (loose wire) because it was reported in several complaints in the past, the failure mode was confirmed like a failure in a component bought (foot pedal mechanism) to supplier (yang ju industries corp.); a capa record was opened car-jrz-00000109 to implement actions that helps to decrease or avoid recurrences.Based in the manufacturing date of the lot (february 2019) reported in the complaint it was confirmed that the product was manufactured before of corrective actions implementation (august 2019).Root cause found to be a lack of crimping in cable and the supplier has since issued corrective actions to eliminate this type of issue from happening in the future.Bd will continue to monitor for any trends.H3 other text : see h10.

• Brand Name: SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11382287
• MDR Text Key: 266926633
• Report Number: 2243072-2021-00612
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 305093
• Device Lot Number: 9044928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1