MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE¿ BI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 383511

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/23/2022

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 bd q-syte¿ bi-extension set had open packaging, compromising sterility.The following information was provided by the initial reporter: "open package: sterilized package was open.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 08-apr-2022.H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unopened nexiva device from lot 1274228 and four photographs.Upon inspection of the samples, a piece of black splice tap was found around the top web of the device.Black splice tape is used when replacing the old roll of top web material with a new one.The black splice tape on this unit was observed to prevent the top web from adhering to the bottom web resulting in an incomplete seal.Additionally, it was identified that a second top web was present beneath the first which indicates that the splice occurred after the printer.This resulted in missing print and additional packaging integrity issues.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error during the packaging process.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported bd q-syte¿ bi-extension set had open packaging, compromising sterility.The following information was provided by the initial reporter: "open package: sterilized package was open.".

• Brand Name: BD Q-SYTE¿ BI-EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14135547
• MDR Text Key: 289464333
• Report Number: 1710034-2022-00193
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 1274228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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