MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. NEEDLE WEISS 16GA 3-1/2IN ANESTHESIA CONDUCTION KIT

Catalog Number 408354

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Investigation summary: our quality engineer was unable to verify the reported complaint. Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process. A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of mixed product / lots with lot #8207685 regarding item #(b)(4). A review of the device history record was completed for catalog #408381 lot 8207685 packed from 18-aug-18 to 24-aug-18 on the anesthesia line. The incorrect product was analyzed inside the unit packages and no records were found that could lead to the incident in question. Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records of this issue, for the lot involved in this complaint. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode for mixed product as no samples or photos were provided. Root cause description: based on the investigation results to date, the root cause was not determinate for this complaint since the defect was not confirmed. Rationale: complaints received for this device and the reported defect will continue to be tracked and trended. The information will be captured in the trend reports and monitored monthly. Collected data are regularly reviewed to identify emerging trends. Based on this, a capa is not needed at this time.

Event Description

It was reported that the newly unpackaged needle weiss 16ga 3-1/2in was measured as an 18 gauge rather than the labeled 16 gauge. As reported by the customer, translated from portuguese to english, "the nurse detected an adverse event when she opened the pack of 16, but when they opened the packaging they reported that the catheter was measuring 18 instead of 16 as reported on the package. ".

• Brand Name: NEEDLE WEISS 16GA 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8383687
• MDR Text Key: 137937697
• Report Number: 9610048-2019-00125
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 408354
• Device Lot Number: 8207685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/01/2019 Patient Sequence Number: 1