MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE; PISTON SYRINGE

Catalog Number 301027

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo and ten loose 5ml syringes were received.The samples were visually evaluated.One syringes had partial print incorrectly applied to the barrel at an angle.Most of the print was missing.Two syringes had missing print with some of the numbers missing or mostly missing from the scale markings.Multiple grad lines were broken up, partially printed.The ink appeared to not have been applied correctly during marking operation.Seven syringes had ink dots/smears outside the printing area.Which is rejectable per product specification.Potential root cause for the missing print and ink smears defects is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 1097108 is considered in compliance with our product specification requirements.Furthermore, 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.

Event Description

It was reported when using the bd plastic non-sterile luer-lok¿ tip syringe there was a damaged, deformed product: device is operable; scale marking issues.The following information was provided by the initial reporter.The customer stated: "there were scale mark issues and the barrels were damaged." bad impression event occurred 120 times.Damaged/broken event occurred 150 times.

• Brand Name: BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12392285
• MDR Text Key: 268991594
• Report Number: 1213809-2021-00604
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301027
• Device Lot Number: 1097108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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