MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE ONLY; PISTON SYRINGE

Model Number 302832

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).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 luer-lok¿ tip syringe only experienced scale marking issues.The following information was provided by the initial reporter: in addition, there is a defective syringe in lot 2278495.Scale marking issue when were defective syringe noticed prior or during use on patient? prior¿was identified by pharmacy tech in iv room.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-apr-2023.It was reported there is a defective syringe.To aid in the investigation, one sample in an opened packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed and the scale marking is skewed.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if there was a jam during the syringe barrel printing process.A device history record review was completed for provided material number 302832, lot 2278495.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

Event Description

It was reported that the bd luer-lok¿ tip syringe only experienced scale marking issues.The following information was provided by the initial reporter: in addition, there is a defective syringe in lot 2278495.Scale marking issue.When were defective syringe noticed ¿ prior or during use on patient? prior¿was identified by pharmacy tech in iv room.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE ONLY
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16640588
• MDR Text Key: 312422239
• Report Number: 1911916-2023-00189
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028321
• UDI-Public: (01)30382903028321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302832
• Device Catalogue Number: 302832
• Device Lot Number: 2278495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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