MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; CONTINUOUS EPIDURAL ANESTHESIA TRAY

Catalog Number EPX795/118BJP

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Brand name, unique identifier and protocol number 510k are unknown.No information has been provided to date.A device history record (dhr) review was not performed as the lot number was not available.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observation, it was confirmed that the catheter was broken.The customer's reported problem was confirmed.The catheter was broken by 2.5 centimeters (cm) in between, breaking at 17.5 cm and 20 cm from the patient side tip.Each fracture surface was oblique, smooth, and almost no elongation was seen.The root cause of the reported event, was speculated that there was a high possibility that the relevant catheter had been broken between the fractured surfaces due to contact with the blade edge during use by the customer.No actions were taken for the primary concern reported.However, this event is unlikely to be attributed to product quality, this event occurrence will be reported to the overseas manufacturers and recorded in the company's database.

Event Description

It was reported that 2 days after indwelling the catheter in the patient, the catheter was broken into two parts and there was leakage.Since the event occurred within the medical dressing tape, it was suspected that the product lot had problem in durability.No patient injury was reported.

Manufacturer Narrative

Other, other text: no same or similar product was sold in the us, it was sold only in japan., corrected data: please disregard the initial report submitted with the mfr number: 3012307300-2022-26129.The report was submitted in error.

• Type of Device: CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15666584
• MDR Text Key: 306800031
• Report Number: 3012307300-2022-26129
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EPX795/118BJP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1