MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK, BD GLASPAK; ANESTHESIA CONDUCTION KIT

Model Number 405671

Device Problem Break (1069)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported when using the bd luer-lok, bd glaspak, the device experienced the depth markings missing (inappropriate graduation markings).The following information was provided by the initial reporter.The customer stated: it was reported the marking isn't working.The markings not working when using spinals.I had another one today did the same thing spinal did not set up marcain not working so now i have had 3 in a week.Lot number for all 3 so far has been.

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd luer-lok, bd glaspak, the device experienced the depth markings missing (inappropriate graduation markings).The following information was provided by the initial reporter.The customer stated: it was reported the marking isn't working.The markings not working when using spinals.I had another one today did the same thing spinal did not set up marcain not working so now i have had 3 in a week.Lot number for all 3 so far has been.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/18/2022.H.6.Investigation: one sample was provided to our quality team for investigation.The anesthetic ampule and contents were examined.No discernible haze or particulate matter was observed, and the returned sample appeared clear.The sample appeared colorless and did not contain any coloration or hue and had the appearance of water.The returned sample met the criteria for passing therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.

• Brand Name: BD LUER-LOK, BD GLASPAK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12921636
• MDR Text Key: 286266025
• Report Number: 2243072-2021-02853
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 00014909764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1