MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 309646

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr? 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 during use of the bd luer-lok¿ syringe sterile, single use when drawing blood, bubbles are forming in the chamber of the syringe slowing down the process.This complaint is for patient #7 of 10.

Manufacturer Narrative

This complaint was determined to be related to report # 1213809-2019-00235 and will be combined there as a result.1213809-2019-00201 is cancelled due to this.

Event Description

It was reported that during use of the bd luer-lok¿ syringe sterile, single use when drawing blood, bubbles are forming in the chamber of the syringe slowing down the process.This complaint is for patient #7 of 10.

• Brand Name: BD LUER-LOK SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8347441
• MDR Text Key: 136611378
• Report Number: 1213809-2019-00201
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 309646
• Device Lot Number: 8337849
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other