MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM

Catalog Number 385100

Device Problem Air Leak (1008)

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

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a bd q-syte¿ luer access split-septum was attached to a dialysis line for blood access.It was connected on a wednesday and accessed on a friday without problems.On the following monday, when accessed with a syringe, air got mixed into the dialysis line.There was no report of injury to the patient and no medical interventions were provided.

Manufacturer Narrative

Results: one used sample without packaging and photos were returned for evaluation.A visual inspection revealed traces of dried media throughout the unit.A microscopic inspection observed the following: - the septum was of a 32 cavity mold.- there was no damage to the top or bottom body - the slit at the top disk was observed to have a severe tear and had the torn portion of the disk folded out/over.- the slit at the top disk was in the correct position (centered) at the septum top disk and there was a tear to the slit.An inspection of the customer's returned photos revealed similar conditional to that of the returned sample.An iso air bubble test was performed and the introduction of air bubbles was not observed during testing of the q-syte unit.A water leak test revealed no leakage when tested in the un-actuated position.A leak test in the actuated position could not be conducted as the testing slip luer would not attached due to the damage to the top disk.The torn portion of top disk was blocking the path.A septum column tear assessment indicated that there was a tear to the column wall and the tear at the top disk lead a tear down the column wall as the torn portion of the top disk pushed in while performing the assessment.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: an absolute root cause for this incident cannot be determined as the evaluation of the device did not reveal any air bubbles when tested.The damage observed in this incident was a severe tear at the slit of the top disk where the torn portion of the disk folded out/over and contributed to a column tear.This type of damage is normally attributed to incorrect usage or excessive actuations and extraneous force.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM
• Type of Device: LUER ACCESS SPLIT-SEPTUM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6432255
• MDR Text Key: 71203067
• Report Number: 9610847-2017-00019
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• 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 Outcome(s): Other