MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 309628

Device Problem Unsealed Device Packaging (1444)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 prior to use with bd 1ml luer-lok syringe the unit package was open thus affecting sterility.The following information was provided by the initial reporter, translated from french to english: the weld on the packaging of the sterile device is offset, so the packaging is not sealed.The protective blister is open.The sampling device is no longer sterile.Impossible to use it.This does not apply to all boxes in the batch.The clean device is available from updms.

Event Description

It was reported that prior to use with bd 1ml luer-lok syringe the unit package was open thus affecting sterility.The following information was provided by the initial reporter, translated from french to english: the weld on the packaging of the sterile device is offset, so the packaging is not sealed.The protective blister is open.The sampling device is no longer sterile.Impossible to use it.This does not apply to all boxes in the batch.The clean device is available from updms.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-sep-2023.H.6.Investigation summary: one sample from lot 3032547 was provided to our quality team for investigation.Through visual inspection, it was observed that the peel tab portion of the package is sealed, and the bottom portion of the blister package is missing the seal causing an open seal allowing the syringe to fall out and exposing the syringe to a non-sterile condition.The condition observed is non-conforming per product specification.Potential root cause for the seal integrity defect is associated with the packaging process.It most likely possible that the web was misaligned going thru the seal section.This defect is occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD 1ML LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17445359
• MDR Text Key: 320255133
• Report Number: 1213809-2023-00802
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309628
• Device Lot Number: 3032547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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