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 Delivered as Unsterile Product (1421)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported 10 bd q-syte luer access split septums was discolored.This occurred 3 times.The additional defect of "discoloration" was observed through the investigation by bd (b)(4) (b)(6) 2022.The following information was provided by the initial reporter: a joint leak occurred in icu.

Manufacturer Narrative

Our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed three stopcock devices connected together along with three q-syte (one q-syte per stopcock) attached to the female luer of the stopcock.A black coloration can be seen at the male luer of each q-syte.It is not possible to determine, based on the photo, if the black coloration is media or an effect of the lighting.The black coloration does not extend past the threads.Additionally, the septum of the q-syte in the middle of the photo has a yellow coloring to it.The photo does not provide evidence of a leak.From review of the photograph, leakage was not confirmed.The photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Discoloration was observed.A root cause could not be determined.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.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 reported defect of leakage could not be confirmed based on the photo evidence.A root cause cannot be established for the unconfirmed defect.The defect discoloration of the septum has been confirmed.Since the device was used, the root cause cannot be conclusively linked to either assembly or application.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed three stopcock devices connected together along with three q-syte (one q-syte per stopcock) attached to the female luer of the stopcock.A black coloration can be seen at the male luer of each q-syte.It is not possible to determine, based on the photo, if the black coloration is media or an effect of the lighting.The black coloration does not extend past the threads.Additionally, the septum of the q-syte in the middle of the photo has a yellow coloring to it.The photo does not provide evidence of a leak.From review of the photograph, leakage was not confirmed.The photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Discoloration was observed.A root cause could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported 10 bd q-syte luer access split septums was discolored.This occurred 3 times.The additional defect of "discoloration" was observed through the investigation by bd sandy plant (b)(6)2022.The following information was provided by the initial reporter: a joint leak occurred in icu.

• 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: 13971833
• MDR Text Key: 288875776
• Report Number: 9610847-2022-00124
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/05/2022

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: Health Professional
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 1210005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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