MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SHARPS CONTAINER

Catalog Number 302406

Device Problem Defective Component (2292)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that bd sharps container was damaged resulting in needle stick injury.Suez supply sharps collectors to (b)(6) hospital.Suez have reported that a multiple staff (waste handlers) have received needle stick injuries from sharps collectors from (b)(6) hospital.Suez have claimed that the sharps collector lids were insufficiently secured to the collector.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: multiple photos were received with the customer's complaint of a needlestick injury.The photos provided shown containers that appeared to be overfilled.When dealing with containers it is imperative to only use until max fill line is reached.This is an issue but should not attribute to the lid not closing.The complaint has been verified but without further information, the root cause of this remains unknown.The device history record review process to verify if there were issues reported like needle poked through sharp container issue during the manufacturing process was not able to be performed since a lot number was not provided.A review of the non-conformance material report was performed; the result showed no issues reported as needle poked through sharp container for the same part number throughout the last twelve months.

Event Description

Photos were received and investigation performed.

• Brand Name: BD SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18179166
• MDR Text Key: 329233401
• Report Number: 2243072-2023-02074
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903024063
• UDI-Public: (01)00382903024063
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302406
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention