MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE¿ LUER ACTIVATED SPLIT SEPTUM; LEUR ACCESS SPLIT-SEPTUM

Catalog Number 380510

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Date 08/17/2017

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 drug leaked from the bd q-syte¿ luer activated split septum, during use.There was no reported medical intervention or serious injury.

Manufacturer Narrative

Investigation: summary: lot analysis, device/batch history record review: no.Reason: dhrs are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable.Findings: review was not conducted because a lot number was not provided for this mdr incident.Sap (qn) database review: yes.Reason: this database tracks any issue during production that would affect product quality findings: this incident was an s1 severity ranking.Review was not conducted for this mdr-level a investigation because a lot number was not provided for this incident.Visual analysis: observations and testing: received one bd q-syte luer access split septum attached to an extension set, fixed nut and no packaging.The q-syte unit was intact and had traces of dried media.Visual/microscopic examination: the septum was of a 16 cavity mold.Observed there were cracks to the top body.Pieces of the top body (polyurethane fell away from the unit.The septum was exposed at this point.No further anomalies or damage was observed on the external areas of the returned q-syte unit.Water leak test (mm-110; could not be conducted due to the condition in which the unit was received.*note: the damage observed to the unit was evidence of potential leakage of the unit in the clinical setting.Investigation samples(s) meet manufacturing specifications: no; the q-syte had cracks with pieces of the top body (polyurethane) breaking away leaving the septum exposed which could result in leakage in the clinical setting.Conclusions: although confirmation of the failure of leakage as stated in the product incident report was inconclusive due to inability of testing based on the unit¿s condition; the damage observed was evidence of potential leakage in the clinical setting.Confirmed there were cracks with pieces of the top body (polyurethane) breaking away leaving the septum exposed.Did the evaluation confirm the customer¿s experience with the bd product? no: confirmation of the failure of actual leakage experienced by the customer was inconclusive due to inability of testing, yet to the damage observed, the q-syte could result in leakage in the clinical setting.Were we able to reproduce the customer's experience with the bd product? no: reproduction of the failure of leakage was not achieved; as testing could not be conducted due to the condition in which the unit was received.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate ¿ a definite source that contributed to the damage and breakage to the top body (polyurethane) was not established.This type of damage is normally attributed to incorrect usage or excessive and/or extraneous force.In-process inspections are conducted during the manufacturing process to identify process changes that could contribute damage and/or adversely affect product performance.Comment: an instruction pamphlet is provided with q-syte product.This information documents the potential failure modes of this device if not used properly.

• Brand Name: BD Q-SYTE¿ LUER ACTIVATED SPLIT SEPTUM
• Type of Device: LEUR ACCESS SPLIT-SEPTUM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6858695
• MDR Text Key: 86088474
• Report Number: 1710034-2017-00196
• 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: 10/19/2017

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 380510
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 10/30/2017
• 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