MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE PRECISIONGLIDE 30X1/2IN

Catalog Number 990193

Device Problem Complete Blockage (1094)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9165869, medical device expiration date: 2024-06-30, device manufacture date: 2019-06-27.Medical device lot #: 9056887, medical device expiration date: 2024-01-31, device manufacture date: 2019-02-26.Medical device lot #: 9112781, medical device expiration date: 2024-04-30, device manufacture date: 2019-04-25.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 that a needle clog occurred during use with a needle precisionglide 30x1/2in.The following information was provided by the initial reporter, "client reports in his clinic is applying lidocaine (anesthesia) and 10 needles caused the following quality deviation: they were clogged, preventing the release of fluid and "appeared to be blunt," said the client.".

Event Description

It was reported that a needle clog occurred during use with a needle precisionglide 30x1/2in.The following information was provided by the initial reporter."client reports in his clinic is applying lidocaine (anesthesia) and 10 needles caused the following quality deviation: they were clogged, preventing the release of fluid and "appeared to be blunt," said the client.".

Manufacturer Narrative

H.6 investigation: dhr there was no documentation for this type of defects during the entire production run of these batches.4 sample were received.They all have the plastic shield.Each of them was connected to a syringe with saline solution.The solution was not possible to expelled.They were inspected with a 30x microscope.There was no damage, bevels were good, etch was good.No defective grind, no hooks were observed.Can¿t be confirmed.Clogged/blocked symptom is confirmed.

• Brand Name: NEEDLE PRECISIONGLIDE 30X1/2IN
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 9525257
• MDR Text Key: 203532616
• Report Number: 3003916417-2019-00647
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990193
• Device Lot Number: SEE. H.10
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other