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

Catalog Number 382534

Device Problem Break (1069)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter broke while retracting the needle.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 382534, batch no.: unknown.It was reported that the catheter sheared/split when retracting the needle.Verbatim: the customer emailed me the following to her quality department which was then forwarded to me: "the catheter sheared/split when retracting the needle.The patient was having an iv inserted, immediate flashback, small advancement and then nurse went to retract needle.Immediately the patient experienced a lot of pain "burning" and when attempted to retract and withdraw needle, resistance was felt.Prior to there was no withdraw back and forth of needle within catheter (which we know could happen) however, wouldn't have believed had i not been present".

Manufacturer Narrative

Investigation: dhr could not be performed as the lot# is unknown.No physical samples were not received for testing and evaluation; one photo was provided for evaluation of this incident the photo displayed a iag bc 20ga unit with the needle spearing thru the catheter tubing at the tip.There was bodily fluids in the catheter tubing.Visual/microscopic evaluation: based on the evaluation of the submitted photo; the needle speared thru the catheter tubing.The defect catheter defective/damaged, was confirmed with the submitted photo.The defect associated with this incident report was caused by the cannula spearing the catheter wall.Bodily fluids observed within the unit indicate the needle and catheter were correctly assembled at the time of use.The condition of the unit in the photo; the catheter would not be able to penetrate the skin.A root caused could not be determined.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter broke while retracting the needle.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 382534 batch no.: unknown it was reported that the catheter sheared/split when retracting the needle.Verbatim: the customer emailed me the following to her quality department which was then forwarded to me: "the catheter sheared/split when retracting the needle.The patient was having an iv inserted, immediate flashback, small advancement and then nurse went to retract needle.Immediately the patient experienced a lot of pain "burning" and when attempted to retract and withdraw needle, resistance was felt.Prior to there was no withdraw back and forth of needle within catheter (which we know could happen) however, wouldn't have believed had i not been present.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 8518656
• MDR Text Key: 142483449
• Report Number: 1710034-2019-00421
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: 30382903825340
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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: Health Professional
• Device Catalogue Number: 382534
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other