MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC; PERIPHERAL IV CATHETERS

Catalog Number 382512

Device Problem Material Puncture/Hole (1504)

Patient Problem Hypoglycemia (1912)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 that bd insyte autog bc needle pierced catheter during insertion.The following information was provided by the initial reporter: multiple attempts fir iv access x 3rns before successfully access.First iv 24g kinked would not flush after good blood return, second attempt made iv 24g buckled skin with threading.Third iv changed to 20g buckled skin with threading.4th iv 24g needle went through the cannula.5th iv successful.Baby having critical low blood sugar levels despite oral treatment ¿ iv treatment delayed due to inability to access an iv.

Event Description

No additional information: it was reported that bd insyte autog bc needle pierced catheter during insertion.The following information was provided by the initial reporter: multiple attempts fir iv access x 3rns before successfully access.First iv 24g kinked would not flush after good blood return, second attempt made iv 24g buckled skin with threading.Third iv changed to 20g buckled skin with threading.4th iv 24g needle went through the cannula.5th iv successful.Baby having critical low blood sugar levels despite oral treatment ¿ iv treatment delayed due to inability to access an iv.

Manufacturer Narrative

Investigation results: our quality engineer inspected the samples submitted for evaluation.Bd received 2 24gx0.75in insyte autoguard devices from lot number 2297773.A gross visual inspection shows that unit 1 has been retracted and there is blood residue in the barrel.Unit 1 displayed a spear though 1/3 of the way near the tip.The reported issue was confirmed for a needle spear through.As the unit is observed to have been used, it is unlikely that the damage occurred during manufacturing.Had the defect occurred during manufacturing, the condition of the catheter and needle would render the device unusable.It is likely that the needle and catheter were inserted far enough to access the vessel, after which the needle was retracted and reinserted to puncture the catheter.The ifu(instructions for use) indicates that if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.Unit 2 does not have any apparent physical damages and no sign of usage.No defects were observed.The report of a kinked catheter and threading difficulty could not be confirmed from the two 24g insyte autoguard units that were provided for investigation.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD INSYTE AUTOG BC
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18222772
• MDR Text Key: 329928770
• Report Number: 1710034-2023-01345
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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: Health Professional
• Device Catalogue Number: 382512
• Device Lot Number: 2297773
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other