MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA; INTRAVASCULAR CATHETER

Catalog Number 381023

Device Problem Packaging Problem (3007)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga the unit package was damaged.This occurred 100 times.There was no report of patient impact.The following information was provided by the initial reporter: packaging was broken, integrity of sterility of product breached.Refer picture attached.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga the unit package was damaged.This occurred 100 times.There was no report of patient impact.The following information was provided by the initial reporter: packaging was broken, integrity of sterility of product breached.Refer picture attached.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 25-jan-2023 h6: investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.The three photographs displayed similarities to that of the returned units.Through the visual inspection of the returned units, 39 of the returned units had sections of the bottom web that had been separated from the top web.The reported issue was confirmed.Further inspection revealed the bottom web had varying degrees of wrinkling including in the seal area.Sections where the seal was still intact had evidence of adhesive residue, although, the adhesive appeared more degraded when comparing to a representative unit.The imprint from the seal machine was present and consistent around the seal area.Finally, when looking at the bottom web against a light source, discoloration of the bottom web could be observed.Based on these observations, it is likely that the seal was adequately formed during packaging of the unit since there is evidence of the adhesive being present/activated and there is evidence that the heated press adequately pressed down on the entirety of the seal.Additionally, given the warping of the bottom web and its discoloration it is likely that the returned units were exposed to environmental factors, like humidity, that damaged the bottom web and degraded the seal.This type of damage may be caused postproduction during shipping or storage (at the customer site) due to inadequate storage/transportation conditions.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA
• Type of Device: INTRAVASCULAR CATHETER
• 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: 16331512
• MDR Text Key: 309134863
• Report Number: 1710034-2023-00086
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201075
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381023
• Device Lot Number: 2179504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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