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

Catalog Number 385100

Device Problems Air Leak (1008); Break (1069)

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

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown. device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using a bd q-syte¿ luer access split-septum stand-alone device on a dialysis patient, the device broke when connecting it to a toray dialysis route and air was mixed in the route.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: device/batch history record review could not be performed as the lot number was not provided.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.One sample unit was received for evaluation by our quality engineer team.Upon examination, tears were observed on the top of the septum and the septum column.An air bubble test did not result in bubbles in either the actuated or un-actuated position.A water leakage test also did not confirm leakage in the actuated or un-actuated position.Conclusions: the defect air in line, as stated as the reported code was not confirmed with the returned q-syte unit.Although air in line was not confirmed, the presence of the column tear would contribute to the air in the line.Confirmed there were slit tears on the septum top and bottom disks.Root cause is indeterminate.A definite source that caused damage to the column wall; which could allow the air to be in the line, could not be established.The failure modes normally attributed to these types of damage are incorrect usage or excessive actuations.An instruction pamphlet is provided with q-syte product.This information documents the potential failure modes of this device if not used properly.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• 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: 7304214
• MDR Text Key: 101358775
• Report Number: 9610847-2018-00034
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 02/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• 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