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

Catalog Number 309110

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/24/2023

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd discardit ii leaked past the stopper.The following information was provided by the initial reporter, translated from french to english: when reconstituting an antibiotic, liquid began to trickle down the plunger once the syringe was filled.2nd syringe with the same problem during the week.

Event Description

Na.

Manufacturer Narrative

Batch number found in an attachment and has been added.

Manufacturer Narrative

A device history record review was completed for provided material number 309110 and lot number 2308159.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.As samples were unavailable for return, twenty (20) retained samples were obtained from the manufacturing facility.Upon review, the retained samples did not display any signs of leakage.Based on the provided feedback, it is possible that the reported leakage resulted from damage in the plunger component.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.If this incident were to reoccur, we would greatly appreciate the opportunity to review the affected sample.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.H3 other text : see narrative below.

• Brand Name: BD DISCARDIT II
• 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: 18346611
• MDR Text Key: 330785103
• Report Number: 3002682307-2023-00359
• 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: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309110
• Device Lot Number: 2308159
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 11/24/2023; 04/26/2024
• Supplement Dates FDA Received: 01/30/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1