MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 50ML LL TIP 1ML 2 OZ IN 1/4 OZ; PISTON SYRINGE

Model Number 309653

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported the luer lock was molded poorly.To aid in the investigation, one sample in an opened packaging blister and two photos were provided for evaluation by our quality team.A visual inspection was performed and the luer lock is damaged.No other defects or imperfections were observed.The two photos provided show the sample received.This defect could occur if there was a jam during the assembly process inducing the symptom reported.A device history record review was completed for provided material number 309653, lot number 1320202.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the assembly process was performed.The conveyors and rails were aligned, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd syringe 50ml ll tip 1ml 2 oz in 1/4 oz the device was deformed and couldn't form a lock.The following information was provided by the initial reporter: poor lure lock forming, not available.

• Brand Name: BD SYRINGE 50ML LL TIP 1ML 2 OZ IN 1/4 OZ
• 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 ; 8015296192
• MDR Report Key: 14244501
• MDR Text Key: 290462231
• Report Number: 1911916-2022-00228
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 1320202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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