MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ DISPOSABLE STERILE SYRINGE

Catalog Number 301942

Device Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

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 during use a 5ml bd¿ disposable sterile syringe was found with volumetric inaccuracy as ¿the head nurse used the syringe to inject the intravenous contrast agent.When the exhausted contrast agent contacted the outer wall of the syringe, the syringe ticks faded seriously.No discoloration occurs with domestic brand syringes.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation results: sample evaluation/ we have been provided with the affected samples.The provided samples showed the mark of the print scale come off.We could confirm the reported issue.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 nº2022 (july 17 - 19th, 2017).Syringes were assembled in machine, nº4255, nº4254, nº4237, and nº4220, in lot #7187047 (july 6 - 17th, 2017) and in lot #7198306 (july 17 - 24th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrels lots #7187011, #7198282, and #7160133 and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #7187015, #7198288, and #7160137 and no problems, defects or qn related to the reported issue were found.Root cause analysis: the process we use to print the scale is called "hot stamping system".A metal stamp is heated at around 100ºc.Between the stamp and the barrel, we interpose a special black printing foil.By pressure, the stamp pushes the printing foil and its component is embedded in the barrel wall.The result is a black scale printed on the barrel of the syringe.In this case the permanency of the scale was affected by the use, it could be affected specially if the external surface of the syringe is in contact with any solution or medication.Based on the information received about the use of the product, we think that the media in contact with the scale being cause of the reported nonconformance.Confirmation: the provided samples presented faded scale marking.We could confirm the reported issue.Capa determination: no - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

• Brand Name: BD¿ DISPOSABLE STERILE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7441062
• MDR Text Key: 105906083
• Report Number: 3002682307-2018-00089
• Device Sequence Number: 1
• Product Code: FMF
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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: Nurse
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 301942
• Device Lot Number: 1707136
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other