MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK TIP SYRINGE WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number 309571

Device Problem Gas/Air Leak (2946)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that air bubbles formed in the bd luer-lok tip syringe with bd precisionglide needle and prevented the consumer from dispensing a full dosage.

Manufacturer Narrative

The date of event has been updated per customer phone call.The following information has been corrected: b.2.Date of event: (b)(6) 2019.

Event Description

It was reported that air bubbles formed in the bd luer-lok¿ tip syringe with bd precisionglide¿ needle and prevented the consumer from dispensing a full dosage.

Manufacturer Narrative

Investigation summary: one photo displaying a loose 3ml syringe with needle attached was received and evaluated.It was observed that there is air bubbles present past the stopper, between the bottom ribs of the plunger rod with the plunger in the bottomed-out position.Potential root cause for the stopper leakage defect could be associated with the assembly process.However, the sample will be required to further evaluate the condition of the components.Samples will be required for further investigation; root cause identification and corrective actions if applicable.A device history record review could not be performed as lot number was unknown.

Event Description

It was reported that air bubbles formed in the bd luer-lok¿ tip syringe with bd precisionglide¿ needle and prevented the consumer from dispensing a full dosage.

• Brand Name: BD LUER-LOK TIP SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8281702
• MDR Text Key: 134356463
• Report Number: 1213809-2019-00114
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 309571
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other