MAUDE Adverse Event Report: BECTON DICKINSON PERISAFE EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	400273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Dear sir, madam.It has been three weeks ago that we contacted you concerning the material used in the bd epidural catheter, 20 gauge closed end (for use with the 3.5" bd epidural needle) - x12938.On 9 july 2024, i was informed team has sent the request to the product stewardship team (bd_moc@bd.Com).However, we have not yet received a response: also, not after sending (reminder) e-mails on 16-7-2024 (to medical.Information@bd.Com).Therefore, i am e-mailing once again to request to you to inform us on the used material of above-stated bd epidural catheter.We need this information urgently, as this bd catheter was broken off during insertion and we need this information for deciding on further imaging/diagnostics and consideration of the necessity of a surgical procedure for the patient.I expect a response to our request at a very soon notice.
Additional Manufacturer Narrative
Two photos were provided from the customer for this investigation.In the 1st photo it is observed the products tyvek with the catalog and batch number, expiration date.The 2nd photo shows an unused and unopened epidural catheter (b)(6) in its sealed package; the package has the description of the device.Physical sample is required to further analyze.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 material passed incoming inspection using which includes visual, dimensional, and functional testing and lot was released with acceptable results.Packaging process was found in compliance.Is important to follow the instructions for use, 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 investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.

• Brand Name: PERISAFE EPIDURAL TRAY
• 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: 19924354
• Report Number: 2618282-2024-00098
• Device Sequence Number: 8375510
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732(11)230418(17)280229(10)3067898
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: NA
• 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
• 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: 3067898
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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: Other
• Patient Sex: Unknown