MAUDE Adverse Event Report: BD Q-SYTE LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 380510

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

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 three bd q-syte luer access split septum had discoloration issues.The following information was provided by the initial reporter, translated from japanese: "the connection part such as the syringe is colored yellow.When i tried to use it, i noticed that the connection was yellow.There are two other unopened ones.".

Event Description

It was reported three bd q-syte luer access split septum had discoloration issues.The following information was provided by the initial reporter, translated from japanese: "the connection part such as the syringe is colored yellow.When i tried to use it, i noticed that the connection was yellow.There are two other unopened ones.".

Manufacturer Narrative

H.6.Investigation: one opened extension set with attached q-syte, two unopened extension sets with attached q-sytes, and four photos were received for evaluation.Upon inspection of the customer photos, the white silicon septum was observed to be yellow, confirming the discolored defect.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.While discoloration of the q-syte septum may be raw material related, however, no quality issues were found for the inspections of the raw material lots used to produce the silicon septum.During the manufacturing process of a sub-lot discoloration may occur during the adhesive curing process if the part remains in the oven beyond a set time.There is an automated rejection set for the parts that are left in the oven beyond the required time period due to a downstream stoppage.Sterilization of the device is not commonly associated with discoloration of the septum.The sterilization records were reviewed, and no quality issues or process deviations were found.Exposure to uv light may also cause discoloration during storage of the unit.Based on the quality team¿s investigation, the root cause was not able to be determined as there are multiple potential causes that cannot be differentiated.H3 other text : see h.10.

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT SEPTUM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12411619
• MDR Text Key: 271328894
• Report Number: 9610847-2021-00414
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 380510
• Device Lot Number: 9273043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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