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

Catalog Number 381412

Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 there was no retraction with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "material no.: 381412, batch no.: 8310576.It was reported that there is a product complaint for an insyte autoguard catheter.It was later reported that the catheter was loose and did not retract correctly.Per email: the catheter was loose and did not retract correctly.".

Manufacturer Narrative

H.6.Investigation: bd received a 24 gauge insyte autoguard blood control unit from lot 8310576 for evaluation.A review of the device history record was performed for the reported lot and no related quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no physical/mechanical damage to the unit.The unit was reset and the needle was inspected.There was no damage to the needle and it retracted successfully without resistance.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no damage was observed a definitive root cause could not be identified.

Event Description

It was reported that there was no retraction with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "material no.: 381412 batch no.: 8310576, it was reported that there is a product complaint for an insyte autoguard catheter.It was later reported that the catheter was loose and did not retract correctly.Per email: the catheter was loose and did not retract correctly.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8549777
• MDR Text Key: 146405567
• Report Number: 1710034-2019-00447
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814122
• UDI-Public: 30382903814122
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 381412
• Device Lot Number: 8310576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Manufacturer Received: 04/06/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/06/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other