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

Model Number 309628

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one photo and one loose 1ml luer-lock syringe (p/n (b)(4) was received.The sample was visually evaluated.Several scratches were visible on the syringe barrel both in and outside of the print area.One scratch cut through the grad lines removing some of the print corkscrewing from the 0.7ml numeral to the 0.5ml numeral.A large gash was evident on the 0.2ml and 0.4ml numeral, removing the print and making the marking illegible.The sample received was non-conforming per product specification.Potential root cause for the damage and missing print defects is associated with the assembly process.Batch number is required to make corrective actions determination.No corrective actions are necessary at this time.The batch number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported when using the bd luer-lok¿ tip syringe there was a scale marking issue.The following information was provided by the initial reporter and translated to english.The customer stated: there was a "wrong of tick print.".

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12753756
• MDR Text Key: 280252818
• Report Number: 1213809-2021-00746
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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