MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT 10 ML SYRINGE; SYRINGE, PISTON

Catalog Number 309110

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd discardit 10 ml syringe leaked past the plunger.The following information was provided by the initial reporter, translated from french to english: the plunger is not tight and blood runs down the sides of the syringe wall, we have 3 boxes of this lot.19 oct 2023 email response: the batch was opened on (b)(6) 2023 and the problem was spotted three times.We have 3 bottles from the same lot.No aes declared.

Manufacturer Narrative

A device history record review was completed for provided material number 309110 and lot number 2302114.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) syringe sample was returned for evaluation by our quality team.Through examination of the sample, leakage was observed.It has been determined that the leakage most likely resulted from damage in the plunger component.This type of damage may occur during the handling of the product through the manufacturing process or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: BD DISCARDIT 10 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18026945
• MDR Text Key: 326808020
• Report Number: 3002682307-2023-00319
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903091102
• UDI-Public: (01)00382903091102
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309110
• Device Lot Number: 2302114
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1