MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD 60ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Model Number 309657

Device Problem Leak/Splash (1354)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that the bd 60ml syringe luer-lok¿ tip experienced difficulty connecting the syringe to the mating component which resulted in leakage.The following information was provided by the initial reporter: i did notice in my last injection that there was no medicine leaking into the 1/4 gap.But i did try to twist the needle particularly hard to minimize the gap, but it still wasn't eliminated.It does still mean, if the needle doesn't seat firmly into the syringe that the measurement of the medicine is incorrect.The needle only twists into the syringe about 3/4 of the way creating a small gap.Medicine get trapped in this gap and does not go into me.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/14/2021.H.6.Investigation: samples received for investigation, upon visual inspection no damage or issues were observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Functional testing was performed, no leakage observed.Based on the analysis of the sample received, the production and quality control areas verify whether there are controls implemented in the process or final inspection that allow identifying this defect during the manufacturing of the batch; currently there is a quality verification as part of the final inspection of the product, which consists of performing a leak test between the assembly of the syringe and the hypodermic needle, the test establishes a sampling of 48 pieces per lot, which results are recorded in the quality inspection record.Due to the above and based on the quality inspection records, no possible root cause related to the reported defect is identified.

Event Description

It was reported that the bd 60ml syringe luer-lok¿ tip experienced difficulty connecting the syringe to the mating component which resulted in leakage.The following information was provided by the initial reporter: i did notice in my last injection that there was no medicine leaking into the 1/4 gap.But i did try to twist the needle particularly hard to minimize the gap, but it still wasn't eliminated.It does still mean, if the needle doesn't seat firmly into the syringe that the measurement of the medicine is incorrect.The needle only twists into the syringe about 3/4 of the way creating a small gap.Medicine get trapped in this gap and does not go into me.

• Brand Name: BD 60ML SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12573423
• MDR Text Key: 274748627
• Report Number: 9614033-2021-00117
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 0195485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Sex: Male