MAUDE Adverse Event Report: ST PAUL PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE; NEEDLE, SPINAL, SHORT TERM

Catalog Number 100/491/718

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that a fracture of spinal needle within patient, obstetrics and gynaecology procedure abandoned and case proceeded to ga.Ct found retained 2mm needle tip in intrathecal sac, planned for retrieval as outpatient.

Event Description

Additional information was received which stated the patient had a successful retrieval of the 2mm needle tip in intrathecal sac via the neurosurgical team on (b)(6) 2022.She had a two (2) day inpatient stay before being discharged home.The reporter stated that the patient is doing ok physically but has been traumatized psychologically and has requested for physiotherapy and psychology outpatient follow up which is being provided.

Manufacturer Narrative

Other text: no lot number was provided; therefore, device history record review could not be performed.A product sample photo was received for evaluation.As there was no returned defected sample, it was difficult to fully investigate the complaint issue by the photo's supplied by the customer.The device kit has more than one needle in it, and although the customer states in the description that the issue was with the spinal needle this could not be confirmed by the photograph supplied, as the photo only shows the pointed section of the needle and not the entire needle.The reported issue could not be confirmed per picture provided for evaluation; no fault found.If the product is returned, the manufacturer will reopen this complaint for further investigation.D4: udi number and g5 are unknown, no product information has been provided to date.D4: device lot number is unknown, no product information has been provided to date.

• Brand Name: PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 176 furlong road; minneapolis, MN 55442
• MDR Report Key: 14435171
• MDR Text Key: 292028055
• Report Number: 3012307300-2022-09086
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/491/718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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