MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1300-22
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device 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 or Problem Description
It was reported that the needle snapped and bent while in use.The event occurred while in use with the patient.There was no patient harm, but the epidural was abandoned, and a spinal was used instead.The patient required a morphine pca by the time the procedure had finished due to the spinal anesthesia wearing off.There was no medical intervention needed.The outcome of the event is resolved.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: four samples were received and a photo of the complaint was provided.On the samples and photos provided by the customer, it is visible that one needle is bent, the second needle is bent and also snapped upon needle hub.Third needle is snapped in two pieces and fourth needle is bent and snapped into three pieces.Based on the samples condition and complaint event description it was believed that the needle bend/snap happened due to a mechanical force which was applied on it.No trend of confirmed similar customer complaints nor internal nonconformity was identified.Therefore, this issue is considered to be isolated incident only.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.

• Brand Name: PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20246408
• Report Number: 3011237704-2024-00190
• Device Sequence Number: 7397860
• Product Code: CAZ
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)280816(10)4425523
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 24-1300-22
• Device Lot Number: 4425523
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MORPHINE.
• Patient Age: 56 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG