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

Catalog Number	400273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Received the information that the epidural catheter got cut during insertion leading to a part of catheter inside the patient leads which on imagined in mri/ct/usg all three modalities could not be found.They informed that probably fell down on the floor.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was noted that the customer was not certain of the batch number provided but only reported it as a "possible" batch.Batch number updated to unknown in section b.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No samples or photos received for investigation.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.It is important to follow the instruction for use, instructions states as follows in the procedure section step#: 3: to avoid damage to the catheter, do not withdraw the catheter through the needle once the catheter has passed beyond the epidural needle tip.Also, in the caution section indicates: do not withdraw catheter through needle.
Event or Problem Description
No additional information.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19973185
• Report Number: 2618282-2024-00099
• Device Sequence Number: 8460700
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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 Catalogue Number: 400273
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided; 09/18/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown