MAUDE Adverse Event Report: COVIDIEN MICRO-BORE BIFURCATE SET

Model Number 2003NPY

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer reports we've had some problems with the covidien bifuses.The nurse this morning told me that when she removed the bifuse from the package last evening, she tightened the caps on tightly.But in the middle of the night, the cap came off the bifuse and the port backed up blood while the iv fluids kept infusing.The patient was receiving post hydration following chemotherapy.The iv fluids being infused was 0.45% ns with mag sulfate 8 meq, infusing at 61.25 cc/hr.We use the covidien needless connector, neutral displacement valve with bifurcate set, 2003npy.We attach a spiros cap to the end of the bifuses to prevent a possible spill while chemo is infusing.The nurses know to tighten the spiros on the bifuse until it is able to spin freely.The nurse who had this patient put the spiros cap on herself and knows for sure that it had been tightened properly.The bifuse broke off where it attaches to the spiros.The bifuse fell on the floor with the iv fluids still running.Since the spiros was still engaged in the patient's port needle, blood backed up through her port needle.The patient's port had to be re-accessed due to the incident.The iv fluids were infusing up until the moment that bifuse broke, or came apart, from the spiros.No harm to the patient other than the discomfort of an unplanned re-access.The re-access was performed without any issues, and her port worked.

Manufacturer Narrative

A dhr review was completed for lot# 15105.There were no manufacturing issues related to the complaint for this lot.Inspection of the sample resulted in noting that there was a crack in the spiros component and in the luer.This complaint will be considered as confirmed.A potential root cause is that the crack in the spiros mail luer component caused the leakage.The fluid appears to have leaked through the crack in the spiros and then up into the collar.The crack in the luer was most likely due to the over-torquing to the spiros component.This would not have caused the leakage since the spiros locks onto the luer permanently.As the spiros is not manufactured by this supplier, no corrective or preventive action is planned at this time.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.

• Brand Name: MICRO-BORE BIFURCATE SET
• Type of Device: BIFURCATE SET
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5815305
• MDR Text Key: 51010357
• Report Number: 1282497-2016-00524
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2003NPY
• Device Catalogue Number: 2003NPY
• Device Lot Number: 15105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1