MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BLOOD COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)

Event Date 08/07/2019

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 (b)(4) has been listed and the (b)(4) registration number has been used for the manufacture report number.Device expiration date: unknown.Device manufacture date: unknown.The customer's address is unknown.(b)(6), usa has been used as a default.Investigation summary: bd had made multiple attempts to reach the customer in order to gather more information on the catalog and lot number; however, the customer indicated that this information was not available.A good faith effort has been made and this complaint will be closed without further investigation at this time.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported that an allergic reaction occurred during use with a unspecified wingset device.The following information was provided by the initial reporter, "the allergic reaction occurred in (b)(6) 2019 during a blood draw.I had burning, itching, redness and hives that extended the length of my vein upward from the puncture to the tourniquet and downwards from the puncture to my hand.My doctors and i need to find out the needle composition as well as that of the lubricant, if any, before we can do any further testing as testing would involve needles and blood draws.Your assistance is appreciated." on (b)(6) 2019: spoke to patient.She stated, she wants to know what materials make up "the butterfly".Patient denies any serious injury, exposure to blood/bodily fluids or medical intervention.Date of event was sometime in (b)(6) but isn't sure because she isn't home.Patient stated she would send me what information she does have." on (b)(6) 2019: customer response, so, to be clear, no i do not have a specific lot #, etc as the phlebotomist on duty when i went to get the information had refused to give it to me.She said she wasn't allowed to give me that information though eventually a few days later after speaking with her supervisor (b)(6), they gave me this pamphlet.I assume they would have that information on my lab sheet/record.Perhaps if someone from your company was requesting it you might have better luck.They have the original blood draw record in which the reaction was supposed to be documented, as well as a secondary complaint i made with the employee who refused to give me the information.In order to get what little information i have.Feedback is appreciated.".

• Brand Name: UNSPECIFIED BLOOD COLLECTION DEVICE
• Type of Device: BLOOD COLLECTION DEVICE
• 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: 8942352
• MDR Text Key: 160536029
• Report Number: 2243072-2019-01838
• Device Sequence Number: 1
• Product Code: JKA
• 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: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• 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): Other