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

Catalog Number INCORRECT ENTRY

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

It was reported that bd emerald syringe leaks past the stopper.The following information was provided by the initial reporter: the 10ml syringes from bd have leaky pistons and that the syringe draws air and blood runs past the koblen plunger.Was there any impact to the patient or the healthcare worker? no patient harm.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.

Manufacturer Narrative

A device history record review was completed for provided material number 307736 and lot number 2202205.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 not returned, twenty (20) retained samples were obtained from the manufacturing facility for review.The retained samples did not display any signs of defect.Based on the investigation results, an exact cause could not be determined for this incident.The material used to manufacture the emerald syringes has been selected and tested to resist normal conditions of use.The assembly machines have an inline detection system that inspects all product and automatically rejects any damaged parts identified.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.

• Brand Name: BD EMERALD 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: 18184796
• MDR Text Key: 329898569
• Report Number: 3002682307-2023-00331
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903077366
• UDI-Public: (01)00382903077366
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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: INCORRECT ENTRY
• Device Lot Number: INCORRECT ENTRY
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1