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

Catalog Number	400273
Medical Device Problem Codes	Material Fragmentation (1261); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer was using perisafe kit, in procedure customer try to retract catheter ,initially it was getting streached and later it got broken inside.Customer has not shared the physical sample, only shared defects in photo.2) as per customer there is no harm to patient/caregiver.3) no.4) during the use.5) no, they have discarded the sample.6) no details shared by the customer.7) this customer is using this product ( perisafe-400273) since 8-10 years, he never faced such issues earlier , so he is also curious why this happened ??? is there any change happened in product materials or is this issue with this batch stocks only.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a040103 - material fragmentation patient problem code: f26 ¿ no health consequences or impact.
Additional Manufacturer Narrative
Two photos received by our quality team for investigation.Through visual inspection, it is observed an epidural catheter in which the front end of the catheter seems stretched and broken (torn).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.It is important to follow instructions for this product, 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.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
Additional information received.Customer was using perisafe kit, in procedure customer try to retract catheter, initially it was getting stretched and later it got broken inside.Status of physical sample details if sample was shipped, please share the tracking details.Was there any harm to the patient/caregiver? (detail).Was there exposure to blood or chemotherapy to mucous membranes or skin? (detail).Was the reported incident noticed before, during or after use? is sample available? if yes, please ship.Was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, medication administration, etc.)? (detail).Provide any additional details.Customer has not shared the physical sample, only shared defects in photo.As per customer there is no harm to patient/caregiver.No.During the use.No, they have discarded the sample.No details shared by the customer.This customer is using this product (perisafe-400273) since 8-10 years, he never faced such issues earlier, so he is also curious why this happened? is there any change happened in product materials or is this issue with this batch stocks only?.
Additional Manufacturer Narrative
Udi related data quality updates only.Request received via email from the fda mdr data systems team on july 16th, 2024 to update the udi, as it was previously submitted incomplete, for this mdr (2618282-2023-00088) within 14 days.This submission is to complete this request.D4 udi corrected to: (b)(4).
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 MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17981503
• Report Number: 2618282-2023-00088
• Device Sequence Number: 19459102
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: (01)30382904002733(17)280229(10)3055650
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10/07/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 07/16/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/15/2023; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown