MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ARTERIAL BLOOD SAMPLING - LINE DRAW DRY HEPARIN 3ML; ARTERIAL BLOOD SAMPLING KIT

Catalog Number 4042-2

Device Problem Disconnection (1171)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.E1.Initial reporter address: unknown.No information has been provided to date.E3.Initial reporter occupation: customer support services h3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the cap fell off, causing a needlestick to the nurse.As a result, the nurse required medical intervention with vgb testing and following up with employee health.There was unknown patient involvement and unknown patient harm reported.This complaint was created to capture the 1st of 2 related incidents.

Manufacturer Narrative

H6.Evaluation codes: updated.Device investigation: no product was returned for investigation.Therefore, we are unable to confirm the reported problem.If we receive the device, we will reopen the investigation for further evaluation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.H4 - device mfg date.

• Brand Name: ARTERIAL BLOOD SAMPLING - LINE DRAW DRY HEPARIN 3ML
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18759305
• MDR Text Key: 336008298
• Report Number: 1217052-2024-00004
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4042-2
• Device Lot Number: 4441352
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention