MAUDE Adverse Event Report: BECTON DICKINSON BD UNKNOWN CSE KIT; ANESTHESIA CONDUCTION KIT

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that bd unknown bd cse kit catheter was defective, damaged it was reported by the customer that we had an imperforated (no holes) catheter, which obviously needed to be re[laced as it would not flush.I had also kept the catheter, but i believe it was thrown after several of us tried to see what the issue was (clearly no holes).Verbatim: rcc received a complaint via email.Email(s) attached.I have had recurrent issues with different components on the bd cse kits.2 epidural catheters: last week we had an imperforated (no holes) catheter, which obviously needed to be replaced as it would not flush.I had also kept the catheter, but i believe it was thrown after several of us tried to see what the issue was (clearly no holes).

Manufacturer Narrative

H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d3: and g1: and the franklin lakes fda registration number has been used for the manufacture report number.

• Brand Name: BD UNKNOWN CSE KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18465864
• MDR Text Key: 332990301
• Report Number: 2243072-2024-00012
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1