MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP; LIQUID MEDICATION DISPENSER

Catalog Number 305207

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd¿ amber oral syringe with non luer tip experienced stopper defective.The following information was provided by the initial reporter: we have had 2 other complaints stating the numbers are getting rubbed off the syringe.

Manufacturer Narrative

Investigation summary: one photo was provided to our quality team for investigation.Through visual inspection the print rubbed off observed.The jammed stopper condition was not observed in the photo.The reported defects could not be confirmed from the photo provided.An unused physical samples from the complaint batch are needed to perform ink permanency testing per internal procedures.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review was completed for provided lot number: 1053334.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

Manufacturer Narrative

H6: investigation summary: one photo was provided to our quality team for investigation.Through visual inspection the print rubbed off observed.The reported defects could not be confirmed from the photo provided.An unused physical samples from the complaint batch are needed to perform ink permanency testing per internal procedures.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review was completed for provided lot number 1053334.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.The following field was updated due to corrected information: b5.It was reported that 2 bd¿ amber oral syringe with non luer tip experienced scale marking issues.The following information was provided by the initial reporter: we have had 2 other complaints stating the numbers are getting rubbed off the syringe.

Event Description

It was reported that 2 bd¿ amber oral syringe with non luer tip experienced scale marking issues.The following information was provided by the initial reporter: we have had 2 other complaints stating the numbers are getting rubbed off the syringe.

• Brand Name: BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP
• Type of Device: LIQUID MEDICATION DISPENSER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15163594
• MDR Text Key: 304902919
• Report Number: 1213809-2022-00447
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305207
• Device Lot Number: 1053334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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