MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported while using bd q-syte luer access split septum the septum lifted up.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported as follows: when the hcp attached and then detached the syringe, the silicon on the q-syte septum was turned up.

Manufacturer Narrative

The following information has been updated: d.10 device available for eval?: yes d.10 returned to manufacturer on: 2022-05-25 h.6 investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used q-syte unit.Additionally, four photos were received for investigation.A gross visual inspection determined that the septum was pushed in.Further microscopic inspection found that adhesive residue was present along the entire rim of the top body and on the underside of the top disk, indicating that adequate adhesion of the septum had been achieved during manufacture of the device.During manufacturing, low bond strength (or insufficient adhesive), septum misorientation, damage to the top body of the q-syte, and damaged tooling may result in the septum being pushed in.Operator-controlled checks for bond strength and septum damage are performed to mitigate the risk from this type of defect.Additionally, preventative maintenance (pm) is performed to ensure tooling is replaced per the quality plan and the equipment is functioning properly.Pm records could not be verified as no lot number was provided.During use, a pushed in septum can occur due to excessive actuations and extraneous force.Given that the sample was returned in a used state, this scenario cannot be ruled out.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.The complaint of a partially detached septum was confirmed but the exact cause was unknown.The physical sample was returned, in addition to four customer-provided photographs.The photographs indicated the same sample state as observed in the returned sample.Evaluation of the returned sample concluded that adequate adhesive coverage had taken place during manufacture, and no potential cause for the partially detached septum was observed.

Event Description

It was reported while using bd q-syte luer access split septum the septum lifted up.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported as follows: when the hcp attached and then detached the syringe, the silicon on the q-syte septum was turned up.

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT SEPTUM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14655806
• MDR Text Key: 298295287
• Report Number: 9610847-2022-00212
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 07/22/2022
• 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