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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 08/28/2020

Event Type  Injury  

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.(b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6).Has been used as a placeholder based on the reported phone area code.Device manufacture date: unknown.(b)(4).Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.  the complaint was deemed as mdr reportable therefore a submission will be performed.  shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the patient developed hives and itching when the unspecified bd insyte¿ autoguard¿ shielded iv catheter was used on them.The patient reportedly always took "2 zyrtec and 2 generic singulair", and used "cortisone cream" for the reaction, but "it didn't help much".This occurred 2 times during use, and this complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "customer called to report that she used two iv¿s and she thinks she is having an allergic reaction.She is sneezing and coughing.She does not have an item number nor a reference number.She did not have much information.I can barely hear her.But she did mention it was a catheter.And that the chloraprep does not give her those reactions." "called and spoke with customer - confirmed had a reaction:hives/itching - asked if she took any medication either topically or orally for the reaction- stated she always takes 2 zyrtec and 2 generic singulair, but she used cortisone cream; stated it didn't help much with the itching/rash.Customer does not have any product to return.".

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10557332
• MDR Text Key: 207813751
• Report Number: 2243072-2020-01459
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2020

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?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention