MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9172820; medical device expiration date: 2022-05-31; device manufacture date: 2019-06-21.Medical device lot #: 9176730; medical device expiration date: 2022-06-30; device manufacture date: 2019-06-25.Medical device lot #: 9205257; medical device expiration date: 2022-07-31; device manufacture date: 2019-07-24." the initial reporter also notified the fda on 8 november, 2019.Medwatch report # mw5090774.Investigation summary: five samples were received.All have plunger rod-rubber stopper and are all the way down.There is no packaging flow wrap, nor tip cap.They are empty and have the barrel label.One is lot# 9176730, other is lot# 9205257, two are from lot# 9172820 and one is labeled as heparin 500 usp units/ml.This heparin syringe is not a bd product its labeled as medefil, inc.(b)(4).Root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Root cause description: root cause could not be determined.

Event Description

It was reported that patient developed lip swelling, hives, tongue swelling, and urticaria after flush with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter:.Patient had implanted port flushed with bd 0.9% sodium chloride for injection from pre-filled syringe bar code (b4).She developed lip swelling, hives, and urticaria.She was treated with iv diphenhydramine and dexamethasone.She was monitored for approx 1hr at which time the md and anesthesiologist determined she was stable for the colonscopy.It was performed with propofol for sedation without event.Prior to discharge, developed hives, lip swelling urticaria and tongue swelling which seemed to be worse per the rn the second time.Pt received 3 different lots of the saline flushes.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9411479
• MDR Text Key: 169254349
• Report Number: 1911916-2019-01274
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 61 YR
• Patient Weight: 93