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

Catalog Number	400273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation and cannot verify the reported issue.Since an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during inspection.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that kit perisafe 18ga 3-1/2in weiss cannula broke and was thought to have the missing piece inside the patient.It was determined that the cannula was shorter and did not break off inside the patient.The following information was provided by the initial reporter: dr.Who informed me that one of their anesthetists found the 20g epidural catheter contained in our epidural kit cod.Cut and 4 cm shorter, following removal from the patient who was to receive epidural anesthesia.From the x-ray examination, the patient does not seem to have the missing piece inside but was unable to receive the required anesthesia / analgesia.Dr.Together with the user anesthetist assume that the catheter was devoid of the 4 cms proximal to the tip before use on the patient.Dr.Is collecting all the information to issue the accident / complaint report.In the next few hours we will have more details on the incident._____________________________________________________________________ reason for use of device: peridual analgesia in spontaneous delivery.Incident description: the catheter is inserted into the peridual space found at 4.5 cm from the skin with slight resistance, therefore in the attempt to retract the catheter, even without exerting any force in traction, resistance to retraction is perceived and the sensation of breaking it.When the catheter is extracted, the needle is missing its extremity end about 5cm.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-31.H6: investigation summary based on the sample provided to bd for evaluation, the reported condition was verified.Although there was a physical sample provided for evaluation a root cause could not be identified.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.H3 other text : see h10.
Event or Problem Description
It was reported that kit perisafe 18ga 3-1/2in weiss cannula broke and was thought to have the missing piece inside the patient.It was determined that the cannula was shorter and did not break off inside the patient.The following information was provided by the initial reporter: dr.Who informed me that one of their anesthetists found the 20g epidural catheter contained in our epidural kit cod.Cut and 4 cm shorter, following removal from the patient who was to receive epidural anesthesia.From the x-ray examination, the patient does not seem to have the missing piece inside but was unable to receive the required anesthesia / analgesia.Dr.Together with the user anesthetist assume that the catheter was devoid of the 4 cms proximal to the tip before use on the patient.Dr.Is collecting all the information to issue the accident / complaint report.In the next few hours we will have more details on the incident.Reason for use of device: peridual analgesia in spontaneous delivery.Incident description: the catheter is inserted into the peridual space found at 4.5 cm from the skin with slight resistance, therefore in the attempt to retract the catheter, even without exerting any force in traction, resistance to retraction is perceived and the sensation of breaking it.When the catheter is extracted, the needle is missing its extremity end about 5cm.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12723306
• Report Number: 2618282-2021-00062
• Device Sequence Number: 4027558
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: 00382904002732
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K953790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 400273
• Device Lot Number: 1028926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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
• Patient Sex: Unknown