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

Catalog Number 301035

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd luer-lok¿ syringe there was an issue with skewed print, black spots on the outside and inside, damaged outside part of barrel, incomplete print or wiped off parts of the scale.

Event Description

It was reported with the use of the bd luer-lok¿ syringe there was 40 syringes with skewed print, 3 syringes with foreign matter in the top, 4 syringes with damaged outside part of the barrel, 80 syringes with black spots on the outside, 4 syringes with black spots on the inside of the plunger, and 10 syringes with incomplete print or wiped off parts the scale.

Manufacturer Narrative

The following field was updated due to corrected information: describe event or problem: it was reported with the use of the bd luer-lok¿ syringe there was 40 syringes with skewed print, 3 syringes with foreign matter in the top, 4 syringes with damaged outside part of the barrel, 80 syringes with black spots on the outside, 4 syringes with black spots on the inside of the plunger, and 10 syringes with incomplete print or wiped off parts the scale.Investigation: 4 samples were received for evaluation.Two of them have embedded foreign matter in the plunger rod (black specks).One syringe has light scale printing, not as dark as the other ones but still readable.One syringe with no defect found.Embedded foreign matter can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the mold and press.The degraded resin can break loose and be molded into components.This is a cosmetic defect only and does not affect the integrity of the syringe.Missing or fading print is considered acceptable if under 50% of any given item (number, letter, or graduation line) is missing and still legible.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8199746
• MDR Text Key: 131607669
• Report Number: 1911916-2018-00777
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 301035
• Device Lot Number: 7206953
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other