MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK; PISTON SYRINGE

Model Number 309680

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no: 309680, batch no: 9157905.It was reported that before use of the bd luer-lok¿ syringe bulk sterile pharmacy convenience pak black embedded particulate was discovered in the barrel of the syringe.Three syringes had this condition.The following information was provided by the initial reporter: black embedded particulate in barrel of the syringe.

Event Description

Material no: 309680, batch no: 9157905.It was reported that before use of the bd luer-lok¿ syringe bulk sterile pharmacy convenience pak black embedded particulate was discovered in the barrel of the syringe.Three syringes had this condition.The following information was provided by the initial reporter: black embedded particulate in barrel of the syringe.

Manufacturer Narrative

H.6.Investigation: three (3) samples and three (3) photos were provided for investigation.The returned samples were visually examined using 10x magnification.Each of the returned samples has a black spot of embedded foreign matter in the barrel which has been circled.The foreign matter was measured using a caliper and was found to range in size from 0.0110 inches ¿ 0.0135 inches.Three (3) photos were also provided for investigation.The three (3) photos show the returned samples individually.Each of the photos shows the embedded black foreign matter in the barrel.Embedded fm 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.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 BULK STERILE PHARMACY CONVENIENCE PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9520696
• MDR Text Key: 192065106
• Report Number: 9610847-2019-00762
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096801
• UDI-Public: 30382903096801
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309680
• Device Catalogue Number: 309680
• Device Lot Number: 9157905
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other