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

Catalog Number 305093

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 and the (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 lid did not shut.This was discovered during use.The following information was provided by the initial reporter: the lid didn¿t shut; when stepping on the foot pedal, some parts might have fallen.

Event Description

It was reported that sharps coll troly foot-op 19gl recykleen lid did not shut.This was discovered during use.The following information was provided by the initial reporter: the lid didn¿t shut; when stepping on the foot pedal, some parts might have fallen.

Manufacturer Narrative

H.6.Investigation: according to the dhr review process; the result showed there were no issues reported like ¿trolley defective or wire/cable broken/snapped¿ during the manufacturing process of the lot number reported under this customer complaint.A ncmr was opened on (b)(6) 2019 for trolley family products, ncmr-jrz-00000905 where the cable was loose on the rivet.A re-work process on raw material (pedal mechanism) was performed to perform a correct crimping on the rivet.In accordance with the photos of the sample and the results of the evaluation performed by bdj, this product reported in the complaint was found acceptable for functionality.The sample is in perfect condition without any abnormality that could lead to malfunctions.The issue reported under this compliant was detected within the manufacturing process, due to inconsistencies in the mechanism provided by supplier.Based on bdj evaluation results and the evaluation of the photos received it was confirmed that there was not defects that could lead to the failure mode detected in the manufacturing process, also it was confirmed that the sample is functional for the intended use.

• 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: 10141308
• MDR Text Key: 199301349
• Report Number: 2243072-2020-00904
• 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: 06/24/2020

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: 9158901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other