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

Catalog Number 385100

Device Problem Split (2537)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).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 a nurse found the septum of a bd q-syte¿ luer access split-septum stand-alone device pushed into the adapter after use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: device/batch history record review findings: 7212772: the lot was built on (b)(4) from 6aug2017 thru 8aug2017 for the quantity of (b)(4) ea.7212775: the lot was built on (b)(4) from 8aug2017 thru 10aug2017 for the quantity of (b)(4) ea.All required challenge, set-up and in-process samples were performed per procedure and all the inspections passed per specifications.No significant discoveries were disclosed as it was noted that there were no reject activity findings throughout the build of this lots that would impact upon the quality of the product.Qn / sap database review findings: no qn¿s were initiated during the production of the sub-assembly lot identified related to this investigation the peura (end user risk analysis) rm5699 rev 5 version d was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis observations and testing: received a total of 3 q-syte units; 2 of the units unused and were received within sealed packages and one unit was used and was received within a paper bag with handwritten words on it.Visual/microscopic examination: unit 1 (used): ¿ the septum was molded using the 32 cavity mold.¿ damage (tears) was observed above the slit of the top septum ¿ the slit was present per specifications ¿ the septum was not pushed into the adapter units 2 and 3 (unused): both of the septums were molded using 32 cavity mold.No physical-mechanical damage was observed on the top disks and the slits were present per specification.The septums were not pushed into the adapters.All units: ¿ during probe insertion it was confirmed both the top and bottom slits were present ¿ the water flowed freely into the q-syte units and out with no obstruction.¿ the flow test passed per specification of 1 liter/hour with the following results: 1.Unit 1 = 26.53 l/h 2.Unit 2 = 32.73 l/h 3.Unit 3 = 29.78 l/h investigation samples(s) meet manufacturing specifications: no, the top disk slit on unit 1 revealed damage (tear).Conclusions: ¿ the flow rate test met manufacturing specifications ¿ the water flowed through the units ¿ the top slits revealed damage (tears) (unit 1) ¿ the septums were not pushed into the adapters.Although the flow rate result passed per specifications, the slit tear (observed on unit 1) could be a contributive factor for the failure of flow rate (if the user was trying to insert devices through the tear instead of through the slit), the tear observed on the top disk is normally attributed to incorrect usage or excessive actuations.Comment: 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.A definite root cause that caused the damage observed with the returned unit could not be identified.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported a nurse found the septum of a bd q-syte¿ luer access split-septum stand-alone device pushed into the adapter after use.There was no report of exposure, injury or medical intervention.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: Q-SYTE 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: 7602813
• MDR Text Key: 111700463
• Report Number: 9610847-2018-00188
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 385100
• Device Lot Number: 7209846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other