MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC; INTRAVASCULAR CATHETER

Model Number 382523

Device Problem Break (1069)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) insyte autoguard bc experienced a needle that broke/detached during use.The needle had been inserted within patient, and was removed after five days.When the device was removed, it was observed that the sheath of the device was missing.Patient underwent ultrasound imaging to identify location of broken portion of device embedded within patient.A follow up appointment was set for the removal of the device sheath, but it has not been specified whether the removal has already taken place.The following information was provided by the initial reporter: cannula dislodging into patient's arm.Description: iv cannula inserted on the (b)(6) 2019 at 1630hrs on ward.Only one attempt made inserted by hmo into left forearm not across a joint.Patient had iv infusion fluids, antibiotics.A microclave clear iv valve was applied when fluid therapy ceased.Removed 5 days later (b)(6) 2019 when 22 ga intravenous cannula was removed from patient left forearm only 0.5 cm of a 3 cm sheath was attached to plastic connector 2.5cm of sheath missing.Ultrasound demonstrated retained product for vascular surgery follow-up.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) insyte autoguard bc experienced a needle that broke/detached during use.The needle had been inserted within patient, and was removed after five days.When the device was removed, it was observed that the sheath of the device was missing.Patient underwent ultrasound imaging to identify location of broken portion of device embedded within patient.A follow up appointment was set for the removal of the device sheath, but it has not been specified whether the removal has already taken place.The following information was provided by the initial reporter: cannula dislodging into patient's arm description: ¿ iv cannula inserted on the (b)(6) 2019 at 1630hrs on ward.Only one attempt made inserted by hmo into left forearm not across a joint ¿ patient had iv infusion fluids, antibiotics ¿ a microclave clear iv valve was applied when fluid therapy ceased ¿ removed 5 days later (b)(6) 2019 when 22 ga intravenous cannula was removed from patient left forearm only 0.5 cm of a 3 cm sheath was attached to plastic connector 2.5cm of sheath missing ¿ ultrasound demonstrated retained product ¿ for vascular surgery follow-up.

Manufacturer Narrative

H.6.Investigation summary bd received one used insyte autoguard bc 22ga catheter/adapter without packaging from material number 382523.Our quality engineer inspected the sample and photograph for evaluation.The lot number is unknown.The catheter/adapter assembly was attached to a needleless connector.One photograph was also submitted which displayed a 22ga catheter/adapter with an attached needless connector.Through the visual examination of the sample, there was approximately 1/8 of an inch of tubing extending from the nose of the adapter.The catheter/adapter assembly revealed the area of separation was on an angle.The tubing edges were sharp, clean with very little strings/flashing.There was also a sharp outward pointed or v shape edges.These may indicate the failure mode was a cut by a sharp instrument or could have been speared by a needle.Your reported issue was confirmed however a root cause could not be determined.A device history record review could not be performed as the lot number is unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9417956
• MDR Text Key: 169411481
• Report Number: 1710034-2019-01296
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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 Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other