MAUDE Adverse Event Report: KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT

Model Number 400273

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the kit perisafe 18 ga 3-1/2 in weiss experienced the catheter breaking apart after use.Patient required medical intervention in the form of a body scan and removal of the embedded piece of the device.No additional information regarding the patient outcome has been provided.The following information was provided by the initial reporter: when removing the perisafe catheter, it is visualized that it does not come out completely.Patient is scanned, but no catheter fragment is seen.Add.Information: i inform you that the patient had to take a lumbar spine scanner without contrast and a consultation with a neurosurgeon.Information received (b)(6) 2020: the catheter fragment was not seen in the lumbar spine scan.Neurosurgeon spoke with patient.I know that patient is fine at the moment.

Manufacturer Narrative

H.6.Investigation: no photos or samples were provided to our quality team for evaluation; therefore, the incident could not be verified.Based on the evaluation of the incoming inspection records of the catheter, no non-conformances or discrepancies were reported.The required inspections according to bd product specifications meets the acceptance criteria.The root cause cannot be associated with the manufacturing process since no indications from the manufacturing records review of situations that could contribute to the customer reported failure of broken catheter.The catheter functional, dimensional and visual inspections were found in accordance with bd specifications.

Event Description

It was reported that the kit perisafe 18ga 3-1/2in weiss experienced the catheter breaking apart after use.Patient required medical intervention in the form of a body scan and removal of the embedded piece of the device.No additional information regarding the patient outcome has been provided.The following information was provided by the initial reporter: when removing the perisafe catheter, it is visualized that it does not come out completely.Patient is scanned, but no catheter fragment is seen.Add.Information: i inform you that the patient had to take a lumbar spine scanner without contrast and a consultation with a neurosurgeon.Information received september 24, 2020: the catheter fragment was not seen in the lumbar spine scan.Neurosurgeon spoke with patient.I know that patient is fine at the moment.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10659910
• MDR Text Key: 211060758
• Report Number: 2618282-2020-00079
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 9065873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention