MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); Injury (2348)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a lot number could not be confirmed for this incident, and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.Device manufacture date: unknown.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 a serious injury occurred with an unspecified bd iv catheter.The following information was provided by the initial reporter, "material no.Unknown.Batch no.Unknown.It was reported 2 nurses were cut on the plastic part of the catheter.There is a very small piece of plastic that is left exposed when the catheter full retracts then sticks out just slightly.When it does this, it brings with it a little of the patients blood.On friday, once of my ace iv start personnel was cut by the plastic piece that had some of the patients blood on it.I was told that a similar thing happened to an l&d nurse as well.You can see from a very close inspection of the pic that tiny plastic piece that sticks out.Hello just an update.She (mother-to-be) was stuck by the plastic piece which jets out on top of the iv cath.I am taping it to a piece of paper and sticking it in your mailbox.She was using the cath correctly, no variances.Unfortunately, it did draw blood and she had to go to emp health.During her visit, she was told by emp health staff that someone else from the floor had also been stuck in the same fashion.So 2 rns stuck by these iv caths!!! basically, the plastic retraction sheath retracts so far that a tiny, very sharp piece is left sticking up.Perhaps this is information that can be shared? at this time, there has been no iv reps seen or heard from." 1 of 2 complaints.

Event Description

It was reported that a serious injury occurred with an unspecified bd iv catheter.The following information was provided by the initial reporter, "material no.Unknown; batch no.Unknown.It was reported 2 nurses were cut on the plastic part of the catheter.There is a very small piece of plastic that is left exposed when the catheter full retracts then sticks out just slightly.When it does this, it brings with it a little of the patients blood.On friday, once of my ace iv start personnel

Manufacturer Narrative

H.6.Investigation summary: one photo was submitted for evaluation.The photo displayed a safety barrel assembly with the needle retracted inside.The unit was taped to a yellow piece of paper, with a black arrow pointing to the top of the grip.The review of the dhr could not be performed as the lot number was not provided.The photo displayed the black arrow pointing to the flange on the white button.The flange is a part of the button and does slight stick up.¿from the customer verbatim : basically, the plastic retraction sheath retracts so far that a tiny, very sharp piece is left sticking up.¿ this is a standard outcome when the needle is retracted.That is in the correct position for the flange on the white button.Conclusion(s): based on the evaluation of the submitted photo; the defect catheter defective/damage could not be refuted nor confirmed.H3 other text : see section h.10.

• Brand Name: UNSPECIFIED BD IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9286949
• MDR Text Key: 171979880
• Report Number: 2243072-2019-02487
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention