MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED 18 GA BD INSYTE AUTOGARD CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Retraction Problem (1536)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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.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.(b)(4).

Event Description

It was reported that unspecified 18 ga bd insyte autogard catheter experienced 1 case of a needle that would not retract, and 1 case of blood leakage during/after retraction of needle.The following information was provided by the initial reporter: material no: unknown.Batch no: unknown.My staff have reported issues with the 18 gauge catheters also, but i don't have the specifics for that item.The staff reported sometimes the retract button does not retract.Also, they reported the antiflow valve is not working causing blood to flow from the catheter as soon as the needle is removed.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that unspecified 18 ga bd insyte autogard catheter experienced 1 case of a needle that would not retract, and 1 case of blood leakage during/after retraction of needle.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.My staff have reported issues with the 18 gauge catheters also, but i don't have the specifics for that item.The staff reported sometimes the retract button does not retract.Also, they reported the antiflow valve is not working causing blood to flow from the catheter as soon as the needle is removed.

• Brand Name: UNSPECIFIED 18 GA BD INSYTE AUTOGARD CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11388310
• MDR Text Key: 234780619
• Report Number: 2243072-2021-00627
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1