MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ 2ML SYRINGE

Catalog Number 307727

Device Problem Leak/Splash (1354)

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

Event Date 06/10/2021

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2103129.Medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-01.Medical device lot #: 103277 medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-22.

Event Description

It was reported that 2 bd emerald¿ 2ml syringes experienced damaged syringe tips.The following information was provided by the initial reporter: during the administration of the radiopharmaceutical, a drop of blood appeared on the pad (this is abnormal because once the syringe has been connected to the tubing, there should be no leakage).The administration of the drug was stopped and the residual activity in the syringe was checked: only 20% of the initially planned activity has been administered (147 mbq out of the 750 mbq).(147 mbq out of the 750mbq) no team member had direct contact with blood or the product used.The leak is difficult to see with the naked eye, but appears to be a physical defect in the syringe: the chip is about 1mm in size and is located on the end of the syringe.

Event Description

It was reported that 2 bd emerald¿ 2ml syringes experienced damaged syringe tips.The following information was provided by the initial reporter: during the administration of the radiopharmaceutical, a drop of blood appeared on the pad (this is abnormal because once the syringe has been connected to the tubing, there should be no leakage).The administration of the drug was stopped and the residual activity in the syringe was checked: only 20% of the initially planned activity has been administered (147 mbq out of the 750 mbq).(147 mbq out of the 750mbq) no team member had direct contact with blood or the product used.The leak is difficult to see with the naked eye, but appears to be a physical defect in the syringe: the chip is about 1mm in size and is located on the end of the syringe.

Manufacturer Narrative

H.6.Investigation: a complaint of damage found on a syringe causing leakage was received by the customer.This is the 1st complaint for leakage on material 300727 and batch 2103129.No photos or samples were returned by the customer.A device history record review was completed by our quality engineer team for provided lot number 2103277.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

• Brand Name: BD EMERALD¿ 2ML SYRINGE
• Type of Device: SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12650566
• MDR Text Key: 277248465
• Report Number: 3002682307-2021-00557
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: Other
• Device Catalogue Number: 307727
• Device Lot Number: 2103277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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