MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 380510

Device Problem Split (2537)

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

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 that the bd q-syte¿ luer access split-septum stand-alone device, bns of the "pink valve separated in 2." it is unspecified when the event took place.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Device/batch history record review: a total of (b)(4) units were manufactured on qfa line 1 from 16april16 through 17april16.All challenge, sept up and in process samples were performed per specifications and no qn¿s were initiated.Qn/sap database review findings: no qn¿s were initiated during the production of the lot number associated to this account.The peura (end user risk analysis) 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 manifold ramp with 7 q-syte units attached to it, observed the q-syte top body of the pink stopcock had been separated from the bottom q-syte body and was connected to an extension set (male end) received along.Visual/microscopic examination: all septums were molded using the 32 cavity mold.All of the q-syte units received revealed damage (scratches, cracking) on their bottom bodies.No other damage was observed.Pink valve: observed the q-syte top body had been separated from the q-syte bottom body at the weld joint (stayed connected to the ext.Set received along), observed the rim of the bottom q-syte body revealed adequate traces of weld.The observed traces of a weld line on both the top/bottom bodies of the q-syte assembly (pink valve); is an indication that a bond was provided during the manufacturing process.The damage (scratches, cracking) observed on the bottom q-syte bodies (all units) appear to be caused by external forces applied to the unit during usage and could be related to the separation observed on the pink valve q-syte.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 that the bd q-syte¿ luer access split-septum stand-alone device, bns of the "pink valve separated in 2." it is unspecified when the event took place.No reports of serious injury or medical intervention noted.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7588570
• MDR Text Key: 111098603
• Report Number: 1710034-2018-00282
• Device Sequence Number: 1
• Product Code: FPA
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 380510
• Device Lot Number: 6099819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other