MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PAIN MANAGEMENT KIT; NEEDLE, CONDUCTION, ANESTHETIC

Catalog Number NCE6061BJP

Device Problems Break (1069); Obstruction of Flow (2423); Material Twisted/Bent (2981)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that the catheter broke during use.After the anesthesiologist completed the placement the nurse attached the catheter, connector, and filter cover.There was no problem when attaching the connector to the filter cover, but it seemed that the product was bent and the liquid transfer stopped.The customer stated that "it was possible that it became tight and broke as a result of putting force into the cover in addition to making it go around when attaching it".No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.G5: no 510k as product not sold in us.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.

Manufacturer Narrative

Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device without its original package was received.Per visual inspection a total of six kinks were observed in the catheter, and upon enlarging it, some kinks were also found to be twisted.The complaint was confirmed, and no further analysis was performed.An unused inventory catheter was found wound around the filter cover in the same way while applying excessive force, the kinking occurred just like with the actual catheter.However, the kink position on the stock catheter did not match the kink position on the returned catheter.Therefore, it is possible that the winding method is different from that of the returned item.In addition, no kink points with twist were observed in the test.There is a high possibility that the root cause was the usage method by the customer.A device history record (dhr) review could not be performed as the lot number was unknown.No actions were taken as the root cause was due to user interface.

• Brand Name: PORTEX PAIN MANAGEMENT KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17761411
• MDR Text Key: 323726693
• Report Number: 3012307300-2023-08986
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

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 Catalogue Number: NCE6061BJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/24/2023
• 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