MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. NEONATAL BLOOD ADMINISTRATION SET WITH 150 MICRON FILTER AND 60 CC BD SYRINGE

Model Number 03-960-10F

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

The 03-960-10f device is a single-use device intended to prepare a small aliquot of filtered blood product for neonatal/pediatric transfusion.The device consists of a single syringe, which is manually attached to a female luer after filling.The syringe is intended to receive filter blood product for transfusion to a patient.The 03-960-10f product is designed with the intention of separating the syringe component from the female luer component after filling.Therefore the syringe/female luer junction is not permanently bonded.The following statement is included in the warnings/precautions section of the instructions for use: "when handling materials that have been in contact with blood or blood components, use appropriate precautions to prevent exposure to blood-borne pathogens" it is unknown if the technician took proper precautions to help prevent eye exposure from the leaking blood.Since the syringe/luer junction is not intended to be a permanent bond, the following instruction is stated in the instructions for use: "tighten all connections before use." the statement from the user's facility incident investigation indicated the technician did not tighten the syringe/luer junction before use.The complaint report also indicated the technician was tapping the syringe to help remove air when the syringe separated from the luer component.The following instructions for dispelling residual air are stated in the instructions for use: "holding the bag and tubing upright, dispose residual air from syringe by gently pushing air back through the filter and tubing." the technician's technique for removing residual air was not a recommended method in the instructions for use.

Event Description

On (b)(4) 2015 a laboratory technician was preparing an aliquot from a primary blood product unit using the 03-960-10f pediatric syringe set.The technician gently tapped the syringe component of the 03-960-10f product to get the air out and the syringe separated from the female luer component, which resulted in blood spraying from the 03-960-10f product and contacting the technician's eye and clothes.The technician went home to change clothes and visited a health clinic due to the eye exposure from the sprayed blood.There was no information available regarding the type of treatment or intervention the technician may have received.The incident occurred in a laboratory setting and there was no patient involvement.No patient medical intervention was required as a result of this incident.The blood lab performed an internal investigation into the occurrence and assigned incident case#.The investigation findings were stated to the (b)(4) medical quality engineer during a phone conversation on january 5, 2016.The blood center's internal investigation determined that the spill occurred when the female luer and syringe junction of the 03-960-10f device detached while the technician was tapping the syringe to remove air.The technician did not tighten the female luer/syringe junction prior to use.The blood center's procedures require tightening the female luer/syringe junction of the 03-960-10f device prior to use.The customer stated there were no broken/cracked components or known material or manufacturing defects with the 03-960-10f device that resulted in this incident.The technician exposure was caused by detachment of the female luer and syringe components.

• Brand Name: NEONATAL BLOOD ADMINISTRATION SET WITH 150 MICRON FILTER AND 60 CC BD SYRINGE
• Type of Device: NEONATAL BLOOD ADMINISTRATION SET
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd; winston salem NC 27103
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer Contact: jessica hughes ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 5399479
• MDR Text Key: 37223789
• Report Number: 1066733-2016-00001
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 01/30/2016

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?: No
• Device Operator: Medical Technologist
• Device Expiration Date: 04/30/2019
• Device Model Number: 03-960-10F
• Device Catalogue Number: 03-960-10F
• Device Lot Number: 141691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention