MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: it was reported by health professional that the patient developed hives and itchiness.To aid in the investigation, one sample with no packaging blister or tip cap was received for evaluation by our quality team.The sample is empty and the plunger rod-rubber stopper is all the way down.No defects or imperfections were observed.Since the sample is empty, no testing on the solution could be performed.A device history record review was completed for provided material number 306547, lot number 1160581.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Sterilization records also show no issues were experienced.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned 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.Capa not required at this time.

Event Description

It was reported that syr 10ml pump compatible saline 10ml fil was used and the patient developed hives and itchiness.The following information was provided by the initial reporter: it was reported by health professional that the patient developed hives, itchiness, and itchiness.Health professional called to report that yesterday, (b)(6) 2021, when nurse was flushing patients chest port the patient began to complain of itchiness and heat.Hives developed all over his body.He was given 25ml of benadryl iv.Customer is doing better, but still has some itchiness.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12629490
• MDR Text Key: 276350139
• Report Number: 1911916-2021-01071
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: 1160581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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