MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE 10ML; INTRAVASCULAR CATHETER

Catalog Number 306546

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Investigation summary: it was reported there was an allergic reaction after use of the product.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a prefilled syringe in its packaging flow wrap.The syringe barrel label confirms the product and lot numbers.No other information can be obtained from the photos.A device history record review was completed for provided material number 306546, lot number 2070497.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd posiflush¿ normal saline syringe 10ml was involved with a patient going to the emergency room.The following information was provided by the initial reporter: i recently had a bubble study done with a saline flush and iv.Both of them were from your company and i had an allergic reaction.Im not sure what i might have reacted to but i was covered in hives and had face swelling and had to go to the emergency room.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE 10ML
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15272038
• MDR Text Key: 298380008
• Report Number: 1911916-2022-00442
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022

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: 306546
• Device Lot Number: 2070497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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