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 Leak/Splash (1354); Split (2537)

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

Event Date 10/29/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the drug leaked from a bd q-syte¿ luer access split-septum stand-alone device during use.No injury or medical intervention.

Manufacturer Narrative

Results: bd received samples and photos from the customer facility for investigation.Following evaluations were made: visual/ microscopic evaluation: the septum was molded using the 16 cavity mold.No physical /mechanical damage was observed on any of the external areas of the q-syte unit.Water leak test: the q-syte unit was connected to the water leak test station and tested in the un-actuated and actuated positions.Leakage was confirmed in the actuated position during testing septum column tear assessment: damage (tear) was observed along the column wall.Bottom septum evaluation: the returned unit was disassembled to evaluate the bottom septum condition.No physical/mechanical damage was observed to the septum bottom disk.Photos of the slit centeredness: septum slit cut was not off center on any of the returned q-syte unit.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion: the defect leakage, as stated as the reported code was confirmed with the returned unit.The root cause of leakage was the vent hole due to the column tear.A definite source that caused damage to the column tear; which contributed to the leakage, could not be established.The failure modes normally attributed to these types of damage are incorrect usage or excessive actuations.

Event Description

It was reported that the drug leaked from a bd q-syte¿ luer access split-septum stand-alone device during use.No injury or medical intervention.

• 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: 7059819
• MDR Text Key: 93772762
• Report Number: 9610847-2017-00161
• 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: 12/21/2017

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: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 10/29/2017
• Supplement Dates FDA Received: 01/08/2018
• 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