MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 300629

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

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 there were no scale markings on the bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: "lack of graduation on the barrel of a 20 ml luer lock syringe.Clinical consequences : unusable syringe, change of device.".

Event Description

It was reported that there were no scale markings on the bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter, translated from french to english: "lack of graduation on the barrel of a 20 ml luer lock syringe.Clinical consequences : unusable syringe, change of device.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-27.H6: investigation summary: one sample of 20ll syringe with reference 300629 and lot number 2102054 and one photo was provided to our quality team for investigation.Upon visual inspection of the sample and photo it can be observed there is no scale printed in the barrel, no other defects can be observed.A device history review was performed for reported lot 2102054 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.While we could not identify a direct issue, it is possible the ink was not correctly transferred to the barrel due to a failure in the patterns that transfers the scale.Based on all our in process inspection plan, this should be an isolated issue and any reoccurrence is unlikely.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12264290
• MDR Text Key: 264722466
• Report Number: 3003152976-2021-00444
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 2102054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1