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

Catalog Number 385100

Device Problem Split (2537)

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

Event Date 02/27/2018

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 the while using the bd q-syte¿ luer access split-septum stand-alone device the user tried flushing the product with saline and noticed the slit in the septum was damaged.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: lot analysis; reason: the lot number related to this investigation was unknown.Visual analysis: observations and testing: received a stopcock extension set with a q-syte full assembly on one port and a q-syte top body only assembly to the other port.Visual/microscopic examination: q-syte top body: the septum was molded using the 16 cavity mold.The slit was present per specification.The slit on the top disk was damaged (tears).No damage was observe on the column wall.Q-syte full assembly: the septum was molded using the 16 cavity mold.The slit was present per specification.The top disk of the septum revealed a ¿u¿ shaped tear.The top disk had been separated (unglued) from the rim.Residual septum material and adhesive was observed on the rim of the top body where separation had occurred.Investigation samples(s) meet manufacturing specifications: no.Q-syte top body only: the slit of the top disk was damaged.Q-syte full assembly: the top disk of the septum revealed a ¿u¿ shaped tear and the top disk had been separated from the rim.Investigation conclusion: the failure described on the event description was confirmed.Root cause: relationship of device to the reported incident: indeterminate.Tear on top disk (septum): the damage (tear-cut) observed on the septum¿s top disk was determined to be a result of the damage due to incorrect usage or excessive actuations.Septum unglued from top rim: the evaluation of the septum revealed evidence of adhesive and septum deposits on the rim.This is an indication that a bond was provided during the manufacturing process therefore, the damage had to be caused by external forces applied to the unit during usage.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: LEUR ACCESS SPLIT-SEPTUM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7334845
• MDR Text Key: 102339302
• Report Number: 9610847-2018-00056
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other