MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SMALL BORE T-PORT EXTENSION SET

Model Number ET04T

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425)

Patient Problem Hypoglycemia (1912)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used extension set, without packaging, was received for evaluation.A caresite valve was attached to the female luer lock adapter of the extension set.In an attempt to replicate the reported event, the returned set-up (with caresite valve still attached) was tested at 10 psi air pressure.Leakage was observed at the caresite / luer lock adapter connection.Upon removal of the caresite valve, a vertical crack was observed along the body of the luer lock adapter.The crack appeared consistent with applied stress.The caresite valve was then tested separately for luer taper, flow, and leakage according to specification with acceptable results.There were no leakages observed and no evidence of any cracks or crazing lines on the caresite valve itself.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Without the lot number, a thorough batch record review could not be performed.Based on the results of this investigation, a definitive conclusion could not be made regarding the cause of the reported event.Although the exact cause of the cracking on the luer lock adapter could not be determined, cracking of this nature can often be the result of an excess torque force in combination with over-tightening the connection.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports a caresite luer access device was attached to the female ending of the extension set to begin an infusion for a one day old baby girl.The clinician smelled tpn during the infusion, and then noticed leaking at the connection to the caresite.The glucose of the baby dropped to 53 mg/dl at that time, then came back up to 84 mg/dl when the iv tubing was changed and the infusion commenced.No treatment was performed for the drop in blood glucose value.There were no outward signs/symptoms of hypoglycemia.Follow-up correspondence received from the reporter indicated further detailed information regarding this event: "glucose routinely checked q 12 hours while on iv fluids.Once nurse noticed what she suspected to be iv fluids leaking onto the linens she checked the blood sugar since there was a chance that the infant had not been receiving iv glucose for an unknown period of time.Blood sugar obtained was lower than had been 8 hours prior.Physician was notified, tubing was changed.Blood sugar was checked again about 2 hours later to assure that it had returned to normal for that patient.Hyperalimentation was infusing via b braun infusion pump at 6.1ml/hour and intralipids were infusing via medfusion pump at 0.4ml/hour.Both of these were infusing through the small bore t port set.Leaking was detected during the hourly iv check around 1500.".

• Brand Name: SMALL BORE T-PORT EXTENSION SET
• Type of Device: SMALL BORE T-PORT EXTENSION SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5519482
• MDR Text Key: 41271376
• Report Number: 2523676-2016-00123
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET04T
• Device Catalogue Number: 471950
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 1 DA