MAUDE Adverse Event Report: BD BD ANGIOCATH AUTOGUARD SHIELDED IV CATHETER; IV CATHETER, 24G

Lot Number 4219570

Device Problems Hole In Material (1293); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Extravasation (1842); Venipuncture (2129)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

Started the iv with a 24g angiocath with no difficulty.No repositioning of the catheter and certainly no re-insertion of the needle after its initial retraction.Since i experienced no difficulty with insertion i turned the iv on it flowed just fine, and i taped down the catheter a couple minute later the pt called to my attention the swelling at the site.I stated at the time that i was very surprised as it was a simple, uncomplicated insertion.I received that iv and re-started another one in the same manner as the first.The pt went to the next room to see the dr.I was called into there for swelling again.I pulled the catheter back slightly to reveal a rapidly leaking hole in the catheter.I did not save the first one but i am certain that it had a hole as well.I am troubled by the fact that i had a completely different lot number with the same issue.Why weren't the defective catheters recalled and replaced after the first incident.Additionally, if the original problem was a misalignment, how was that not readily apparent during the mfg.When the needle is inserted into the catheter and makes a hole only 2 things can happen: the needle continues outside of the catheter which would have been readily apparent, or the needle is withdrawn and reinserted and by that very act you would know there was a hole.I would like an answer to this issue.Additionally when the second problem occurred, i called (b)(4) and she had someone else call me back.He had no idea what was going on and could not answer my questions.He told me he could not guarantee that my 4 replacement boxes would be manufactured after the original problem was remedied.He said he couldn't do that.Sure you can.You go to the quality engineer and ask them when the problem was fixed then send me a lot manufactured after that date.Finally, i am one rn in a solo practice and i've had 2 different lots and holes in different places.Imagine a box being used in an er where multiple people are getting their catheters from who have no idea that their failed iv's were a result of a known defect.Pts and clinicians deserve more.You should not have kept defective catheters out in the market.Reason for use: ra.Also see mw5043094.

• Brand Name: BD ANGIOCATH AUTOGUARD SHIELDED IV CATHETER
• Type of Device: IV CATHETER, 24G
• Manufacturer (Section D): BD
• MDR Report Key: 4847633
• MDR Text Key: 5871072
• Report Number: MW5043095
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 4219570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2015
• Patient Sequence Number: 1
• Patient Age: 59 YR