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

Model Number	400273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10659910
• Report Number: 2618282-2020-00079
• Device Sequence Number: 2670916
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K953790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/10/2020
• Supplement Report FDA Received Date: 10/12/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention