MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381834

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that 5 bd insyte¿ autoguard¿ shielded iv catheters' packaging units were not correctly heat-sealed, compromising their sterility.The following information was provided by the initial reporter: "during qc incoming control, according to our medical devices sampling procedure ((b)(4)), qc analyst found on 5 unit visually analyzed (ref.Testing standard document for 20 g venous catheter insyte autoguard (b)(4) and relevant method (b)(4) for physical examination), 5 pieces of bd insyte autoguard (bracco batch 2200887) not correctly heat-sealed, and therefore whose sterility is compromised.The primary packaging opened is classified as a critical defect and critical defects are not allowed for the approval of the batch".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs which displayed five 20g insyte autoguard units with black tape on the underside of the top web.The five units are opened where the tape is present.The reported issue was confirmed.The black tape is most likely splice tape used when testing the vision system or realigning/splicing new rolls of top web.It is the operator¿s responsibility to follow the splice through the machine to ensure it travels through the machine as desired and to make sure that the row with the splice is discarded by the vision system at the end of the machine.There is a 100% vision inspection system for detecting splice tape.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 and inspection process.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 that 5 bd insyte¿ autoguard¿ shielded iv catheters' packaging units were not correctly heat-sealed, compromising their sterility.The following information was provided by the initial reporter: "during qc incoming control, according to our medical devices sampling procedure (b)(6), qc analyst found on 5 unit visually analyzed (ref.Testing standard document for 20 g venous catheter insyte autoguard tsd-b135103 and relevant method met-b059110 for physical examination), 5 pieces of bd insyte autoguard (bracco batch 2200887) not correctly heat-sealed, and therefore whose sterility is compromised.The primary packaging opened is classified as a critical defect and critical defects are not allowed for the approval of the batch".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• 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: 13966323
• MDR Text Key: 288669601
• Report Number: 1710034-2022-00160
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 1336431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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