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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd luer-lok¿ syringe sterile, single use was forming bubbles in the chamber of the syringe when drawing blood.No serious injury or medical intervention was reported.

Manufacturer Narrative

This complaint was determined to be related to report # 1213809-2019-00235 and will be combined there as a result.1213809-2019-00192 is cancelled due to this.

Event Description

It was reported that bd luer-lok¿ syringe sterile, single use was forming bubbles in the chamber of the syringe when drawing blood.No serious injury or medical intervention was reported.

• 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: 8341550
• MDR Text Key: 136612906
• Report Number: 1213809-2019-00192
• 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: 02/14/2019
• 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