MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 ML BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Model Number 302832

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported by the health professional the items are leaking at the bottom of the plunger.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.The sample has 20ml of a clear substance.A visual inspection was performed and no damage, imperfections or leakage is observed.As the sample is contaminated with an unknown substance, no further investigation was completed.A device history record review was completed for provided material number 302832, lot number 1056997.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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 could not be confirmed and a probable root cause could not be offered.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 that the 30 ml bd luer-lok¿ tip syringe experienced leakage.The following information was provided by the initial reporter: the items are leaking once solution is drawn into them.The leaking looks like its coming from the bottom part of the plunger.

• Brand Name: 30 ML BD LUER-LOK TIP SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12333644
• MDR Text Key: 266977372
• Report Number: 1911916-2021-00839
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028321
• UDI-Public: 30382903028321
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1056997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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