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	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
When using epidural kit no 400273, a piece of the epidural catheter was left in the patient.We no longer have the pack.Additional information: there is no impact on the patient just now, the did a lot of extra examinations and test but so far, they can¿t find any damage.There are no sample to be collected and no pictures of the product available.
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
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.The catheter complies with inspection requirements and were found in accordance with bd specifications.Potential root cause can be directed to possible handling issues.As per complaint additional information provided by the customer ¿catheter was withdrawn through the epidural needle¿.As it is explained in the instructions for use, this practice may increase the risk of catheter damage and therefore it is not recommended.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Follow up mdr for correction, annex f code updated.
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: 19771454
• Report Number: 2618282-2024-00086
• Device Sequence Number: 18170433
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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: 3055650
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/26/2024; 08/07/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 07/26/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown