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

Catalog Number 381444

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Itching Sensation (1943)

Event Date 05/24/2019

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 that jagged and torn catheter was found with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "the customer said that the patient feel itchy when they inject it.(verified to not to be true by hospital).Hospital called regarding this incident - she corrected the incident, she said that it had nothing to do with the patient feeling itchy rather the end of the catheter was jagged and torn up before it was ever placed.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the returned sample provided.Bd received one 18ga insyte autoguard catheter-adapter assembly along with a piece of top web packaging from lot number 9045918.Through the visual evaluation of the unit, the catheter tubing revealed two v-shaped cuts near the tip.The catheter tip edge appeared ¿flattened¿ due to the damage observed.The reported issue was confirmed.Since the unit was received out of its original packaging, bd could not determine a definite root cause.We could not be determined if the damage resulted from the manufacturing of the device or from the user environment.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 jagged and torn catheter was found with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter."the customer said that the patient feel itchy when they inject it.(verified to not to be true by hospital).Hospital called regarding this incident - she corrected the incident - she said that it had nothing to do with the patient feeling itchy rather the end of the catheter was jagged and torn up before it was ever placed.".

• 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
• MDR Report Key: 8708306
• MDR Text Key: 148655603
• Report Number: 1710034-2019-00638
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: 30382903814443
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 381444
• Device Lot Number: 9045918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other