MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL MEXICO 22.7L RED; SHARPS CONTAINER

Catalog Number 300182

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 05/05/2021

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 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.

Event Description

It was reported that sharps coll mexico 22.7l red lids were damaged.This occurred on 2 occasions.The following information was provided by the initial reporter: when reviewing the product received, it was detected that in one of 3 sealed boxes, there were 2 lids damaged.One of them was broken in its corner, and the second one was observed with cracks.

Manufacturer Narrative

H6: investigation summary the customer provided photo evidence of broken lids upon receipt.These photos were investigated by the supplier and the complaint was verified.According with the evidence received (pictures) and the description of the issue the final customer received three (3) pcs and two (2) of the pieces present the damaged mentioned (broken & cracked).The standard pack provided from flex due the requirements to flex is packing twelve (12) pieces per box and the part broken was arrived as a part of the shipment at the user.There are probabilities of this product was manipulated and changed from the original packaging to a non-suitable packaging.With all this information it was concluded that this product had additional handling by a distributor (procomsa).For this reason, it can be concluded that there are many variables that could generate this failure mode because the distributors can do partial sells and the controls to handle remaining material is unknown, therefore, the likelihood of non-controlled handling within distributor facilities could happen and leads to product damages.Potential root causes include: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non controlled handling within distributor facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that sharps coll mexico 22.7l red lids were damaged.This occurred on 2 occasions.The following information was provided by the initial reporter: when reviewing the product received, it was detected that in one of 3 sealed boxes, there were 2 lids damaged.One of them was broken in its corner, and the second one was observed with cracks.

• Brand Name: SHARPS COLL MEXICO 22.7L RED
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12022047
• MDR Text Key: 266852134
• Report Number: 2243072-2021-01706
• 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: 09/14/2021

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: 300182
• Device Lot Number: 1096917
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1