MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INJECTION NEEDLE; INJECTION NEEDLE WITH LUER LOCK

Model Number 26178P

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: findings confirmed.Tip is broken off.The event is filed under internal karl storz complaint id (b)(4).Due to the fact there was a similar event in the same timeframe of 01/11/2021-01/18/2023 that caused or contributed to a serious injury.

Event Description

It was reported that there was an event with a product 26178p injection needle with luer lock.According to the information received; the tip of needle broke inside of a patient.Hospital wrote up a patient incident on the event and would like to send the unit to storz for further evaluation and assistance in determining potential issues.No patient harm, it was reported all pieces were retrieved.

Manufacturer Narrative

Per manufacture's investigation conclusion and root cause: the cause of this damage is due to user negligence.Visual inspection shows the broken-off cannula remnant is bent.The cross-section is also deformed when viewed from above.This is due to the application of force by the user.Since the article is already from 2018, a production error can be excluded here.

• Brand Name: INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE WITH LUER LOCK
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 16286149
• MDR Text Key: 308679185
• Report Number: 9610617-2023-00018
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951190
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: Health Professional
• Device Model Number: 26178P
• Device Catalogue Number: 26178P
• Device Lot Number: TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 64 KG