MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II¿ SYRINGE; PISTON SYRINGE

Catalog Number 300849

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 5 bd discardit ii¿ syringes had leakage issues.The following information was provided by the initial reporter: ".While administering the medicine the medicine leaked behind the plunger.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-01-28.H6: investigation summary: the dhr of material number 300849 and lot number 1129916 was checked and no quality notifications were recorded on this lot.Three samples and no photographs were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 300849 and lot number 1129916 for investigating the reported defect of air bubble or leakage past plunger.The three customer received samples were tested for air bubble or leakage past plunger in them.The samples confirmed on simulation that there was air bubble formation and there was leakage past plunger.The defect is confirmed.The customer returned plunger samples were identified as cavity number 18, 23, 28.We simulated the defect on current lots and on the retention lots of 1129916 on the same cavity 18, 23 and 28 and it did not show any air bubble or leakage past stopper.The three samples were checked for their ods and were found to be slightly deviating from the specification but the same cavity no retention samples did not have deviation in them.The dhr was thoroughly reviewed.The ipqc log sheets were checked for any quality notifications.The cavity no.18,23 and 28 were also checked for any maintenance rework and none was found in the last 4 years from its production to dispatch of the this lot.The root cause could not be determined.H3 other text : see h10.

Event Description

It was reported 5 bd discardit ii¿ syringes had leakage issues.The following information was provided by the initial reporter: "while administering the medicine the medicine leaked behind the plunger.".

• Brand Name: BD DISCARDIT II¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13122432
• MDR Text Key: 286533846
• Report Number: 2243072-2021-03014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300849
• Device Lot Number: 1129916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2021
• 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