MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL MINIPACK; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 100/491/718

Device Problems Disconnection (1171); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Other text: b3: date of event and d4: udi section are unknown, no information available.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the clinician experienced disconnection of the device.The filter and connection keep coming loose despite reinforcement with tegaderm.The experienced clinician has utilized this product before and is familiar with them.Medical intervention was required: a complete epidural re-site due to the breakoff of the filter.Adverse effects have not been reported.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL MINIPACK
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17361301
• MDR Text Key: 319398916
• Report Number: 3012307300-2023-07307
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/491/718
• Device Lot Number: 4220534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention