MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

Catalog Number 309050

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: an investigation has been completed with no pictures or affected sample available to examine.Regrettably, the affected sample was not available for our evaluation so we could not performed an accurate investigation.We can state that the syringes reported meet the product specs and recommended values in the product standards.On the other hand, either the medication/drug used by the customer or a special method of use (high temperatures, pressures, several uses, etc.) could affect the sliding properties of the syringes.Based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.Sample evaluation n/a bhr review we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine nº2024 ((b)(6) 2017).Syringes were assembled in machine, in lot #7234165.Research has found no problems, defects or qn related to the reported issue.We have also reviewed the sliding test performed for this batch ((b)(6) 2017), and all values were found within specifications.Based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

Event Description

It was reported that there was plunger difficulty while using a bd discardit¿ ii syringe.There was no report of exposure, injury or medical intervention.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7355173
• MDR Text Key: 103041148
• Report Number: 3002682307-2018-00055
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 309050
• Device Lot Number: 1708122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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