MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DISPOSABLE BIOPSY NEEDLES; DISPOABLE BIOPSY NEEDLES

Catalog Number DBN-08-19X

Device Problem Dull, Blunt (2407)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint investigation is currently ongoing.As it was stated in the description section that the clinical consequences for this issue resulted "in a more important bleeding from the biopsy site.", ad-tech contacted the distributor for additional information in regards to patient impact.Ad-tech is currently waiting for a response from the distributor.A second failure of similar nature was also mentioned in this vigilance report for a biopsy needle from lot 208140580.A separate mdr was filed for this issue under 2183456-2016-00005.

Event Description

On june 7, 2016, ad-tech medical instrument corporation received an email from the regulatory body in (b)(6) requesting additional information on a vigilance report that had been reported by a (b)(6) customer.It was found that "when performing a biopsy, the inner cannula gets stuck and the cut is not good.The incident happened twice with 2 needles coming from the same batch/lot." ad-tech contacted the distributor for this customer for additional information and obtain a copy of the vigilance report.It was stated that they were working with the customer to resolve this issue.According to the report, the customer stated the clinical consequences for this issue resulted "in a more important bleeding from the biopsy site.".

• Brand Name: DISPOSABLE BIOPSY NEEDLES
• Type of Device: DISPOABLE BIOPSY NEEDLES
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 1901 william street; racine WI 53404
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 1901 william street; racine WI 53404
• Manufacturer Contact: kathleen barlow ; 1901 william street; racine, WI 53404 ; 2626341555
• MDR Report Key: 5784229
• MDR Text Key: 49233406
• Report Number: 2183456-2016-00006
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K924348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: DBN-08-19X
• Device Lot Number: 208140580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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
• Patient Outcome(s): Other